What to Expect When You're a Clinical Trial Volunteer

By Marisa Sibley, MS, CCRC

Originally published in the May/June 2018 Issue of Ellis County Living Magazine

The experience of participating in a clinical trial is often misunderstood. When I talk to people unfamiliar with clinical trials about participation, the first response I usually receive is, “You want me to be a guinea pig?” Being a human lab rat is the most common stereotype associated with participating in a clinical trial, unfortunately due to historical bad examples. Today clinical trials are highly regulated and monitored to assure that research is ethical and that the safety of the participant is protected to the fullest extent. So let’s clear the air. What is it really like to participate in a clinical trial?

Volunteering for a clinical trial will always start with informed consent. Informed consent is the process by which you learn the details about a clinical trial in order to make an informed decision about whether participating is right for you. We start with the informed consent document. This document provides an in-depth look at the purpose of the research study, information about the medication or product under investigation, the study procedures, your responsibilities as a volunteer, risks, benefits and more. The consent document is not a contract, but you must sign it to state that you have read and understand the information in order to participate in a clinical trial. Through the duration of a trial, you can ask questions to the Investigator (Doctor) and his/her study staff at any time. The important thing to remember is that your participation is voluntary, and you can choose to withdraw from the study at any time and for any reason.

Once you have agreed to participate in a clinical research study, you will be asked to come to the research clinic for a number of visits. Depending on the length of this study, this could be only a couple of visits up to several over a long period of time. At each visit, you will receive the study medication, laboratory tests (for example, HbA1c for Type 2 Diabetes studies), ECGs and vital sign assessments, and physical examinations/visits with the doctor at no cost. Participating in a research study may also involve keeping a diary or completing questionnaires about your health. Your health is followed very closely during a research study, perhaps in more depth than you would receive as standard care. Once a study is over, follow-up care is also provided. This may include alternative treatments that are available, learning more about your condition, and any other information about your participation in the study that may be available (for example, results of the trial).

At the end of the day, our thoughts and perceptions of clinical trials tend to stray far from the reality of what it is like to participate. Our physicians at ClinPoint Trials, Dr. Ledbetter, Dr. Pickens, Dr. Linguist and Dr. Haque, are passionate about seeing medicine advance and call on our community to learn more about how they can be involved in advancing medicine for the future generations. If you are interested in learning more about clinical trials or participation, contact or visit the ClinPoint Trials offices.

If you have been diagnosed with Type 2 Diabetes, you may qualify for a clinical research study.  Call the ClinPoint Trials offices at (972) 937-1640 for more information about upcoming studies for Type 2 Diabetes.

What You Need to Know about Anemia and Kidney Disease

What is anemia?

Anemia is a medical condition characterized by a short or low supply of red blood cells. Red blood cells are responsible for carrying oxygen from your lungs to the rest of your body. This gives you the energy you need for all sorts of daily activities. 

What are the symptoms of anemia?

There are several symptoms associated with anemia. 

  • Looking pale or feeling tired/low on energy

  • Having a poor appetite

  • Having trouble thinking or difficulty thinking clearly

  • Experiencing dizziness, headaches, rapid heartbeat or short of breath

  • Feeling depressed

How do you know if you have anemia?

You cannot rely on symptoms alone to know if you have anemia. Not everyone experiences symptoms. A great way to find out if you have anemia is to have your doctor perform a simple blood test to measure your hemoglobin level. This should be done at least once per year. Hemoglobin is the part of the red blood cells that carry oxygen from the lungs to the rest of your body. Low hemoglobin levels often determine a diagnosis of anemia. 

What causes anemia and how do you treat it?

The way anemia is treated depends on what it is caused by, which can vary person to person. If anemia is caused by chronic kidney disease, treatment options usually include drugs called erythropoiesis stimulating agents (ESAs) and extra iron supplementation. ESAs assist in the production of red blood cells and are usually injected under the skin. If you have low iron levels, your body doesn't have adequate resources to make red blood cells. Low iron levels also cause ESAs to not be as effective as they could be. Iron supplements may be provided in pill form or as an infusion directly into a vein. 

What causes someone with chronic kidney disease to get anemia?

The kidneys are responsible for making a very important hormone called erythropoietin (EPO). Hormones act as messengers that help you to stay healthy. EPO drives the body to make red blood cells. Someone with kidney disease doesn't make enough of the EPO hormone. As a result, the red blood cell count drops and anemia is developed. It is an extremely common issue for individuals with kidney disease. Anemia can develop at any stage of kidney disease, and is especially common in individuals that have diabetes, are African-American, have moderate or severe loss of kidney function (stage 3 or 4 chronic kidney disease), have kidney failure (stage 5 kidney disease), or are female. 

Visit with your doctor for more information about anemia and chronic kidney disease.

If you have been diagnosed with anemia due to chronic kidney disease, you may qualify for a clinical research study. Call the ClinPoint Trials offices at (972) 937-1640 for more information. 

Winning the Battle Against Pre-Diabetes

By Marisa Sibley, CCRC

Originally published in the January/February 2018 Issue of Ellis County LIVING Magazine

“The greatest victory is that which requires no battle.” – Sun Tzu, The Art of War

I was introduced to Type 2 Diabetes as a young child. Not because I struggled with the condition, but because I had family members who did. I watched them take daily medication, check their blood sugar throughout the day, and eventually perform insulin injections before they would eat their meals. Unfortunately, all of these things were necessary to help manage their condition and help their bodies function properly.

In 2015, 30.3 million Americans, or 9.4% of the population, had diabetes. This is a number that has only continued to rise. However, what is perhaps even more staggering is the number of individuals with pre-diabetes (i.e. blood glucose levels higher than normal but not high enough to be diagnosed with diabetes). According to the Centers for Disease Control and Prevention (CDC), approximately 86 million Americans age 20 and older (37% of the population) have pre-diabetes.

This equates to 1 out of every 3 people. Of this group, 90% don’t know they have it.

“Diabetes can lead to potentially serious health complications. Generally, the effects of high blood sugar are separated into vascular complications such as blocked arteries in the heart, legs, and brain leading to heart attack and strokes, as well as damage to the kidneys, nerves in the feet, and blindness. Individuals with pre-diabetes still have the opportunity to change the course of their health through prevention efforts.” – Dr. Thomas Ledbetter, Medical Director and Principal Investigator

Prevention of diabetes starts with understanding how our bodies function and how the condition develops. When we eat, our bodies break down the carbohydrates in our food into a sugar called glucose. Our pancreas releases a hormone called insulin, which acts as a key to let this glucose into our cells to use for energy to function. For individuals with pre-diabetes, the cells don’t respond normally to insulin. That is, the body develops a sort of resistance to insulin. In effect, the pancreas attempts to make more insulin to try to keep up with the amount of glucose in the blood and get the cells to respond to insulin’s message. Eventually the pancreas cannot keep up with the demand, leading to the amount of glucose in the blood to rise and setting the stage for Type 2 Diabetes down the road.

So what can we do to prevent developing diabetes?

  • Maintain a healthy weight. Research suggests that an overweight person losing 7% of their body weight can lower their risk of developing diabetes by 60%.

  • Engage in a physical activity you enjoy at least five days out of the week for 30 minutes per day.

  • Nourish your body by eating well and intuitively. Pay attention to your physical signal for hunger, eat slowly, and stop eating when you are full. Consider incorporating fiber-rich fruits and vegetables, whole grains and legumes, and lean proteins like chicken or fish into your meals.

  • Limit the intake of added sugars. The average adult needs 6-11 servings of carbohydrates per day according to the National Dietary Guidelines. Depending on your height and weight, activity level and gender, your intake needs may vary. A Registered Dietitian (RD) can help you assess your specific carbohydrate and other macronutrient needs.

  • Check your blood sugar and HbA1c, which is a value that reflects your blood glucose levels over an average of three months. This can be done with a simple blood test.

I am 25 years old. I want to believe that I have a long, healthy life ahead of me. This may be out of my control. For example, a contributing factor to the development of Type 2 Diabetes is genetics. Diabetes runs in my family, so I am certainly at risk. However, regardless of outcomes, I believe that my choices today matter. All of us, but especially my generation, have the opportunity to engage in an exciting victory against pre-diabetes, avoiding the battle all together through efforts of prevention, potentially changing the health of our population for generations to come.

ClinPoint Trials will be hosting free health screenings for adults, starting January 19th and 20th, 2018. Assessments will include, but are not limited to blood pressure, blood glucose, and HbA1c. Call (972) 937-1640 to schedule your free health screening today.

If you have been diagnosed with Type 2 Diabetes, you may qualify for a clinical research study. Call the ClinPoint Trials offices for more information about upcoming studies for Type 2 Diabetes.

Alzheimer's Awareness - Making Progress Together

By: Marisa Sibley, CCRC

Originally published in the November/December 2017 Issue of Ellis County LIVING Magazine

I remember sitting in my undergraduate neuroscience class listening to my favorite professor explain the intricacies of the human brain. As the most complex organ in the human body, it produces our every thought, action, memory, feeling and experience of the world. It was ironic to even consider wrapping my mind around its complexity. As medicine and technology has advanced over time, we have been able to study more and more about certain areas of the brain, how they function, and how they affect other parts of the body. Yet, there is still a great amount of information about the brain that is unknown. We have questions that we do not yet have answers to, which can be frustrating for individuals and families that are affected by neurological diseases like Alzheimer’s.

According to the Alzheimer’s Association, Alzheimer’s disease is the most common form of dementia, which is a general term for the loss of cognitive abilities, like memory, that negatively impact an individual’s daily life. An estimated 5.5 million Americans are currently living with Alzheimer’s disease. It is not a normal part of aging, although the greatest risk factor for the disease is increasing age. Alzheimer’s is a progressive disease with symptoms of memory loss and the lack of ability to carry on a conversation and respond to the environment. These symptoms worsen as time passes, which can be extremely frustrating for individuals and families that are affected.

Alzheimer’s disease is one of the most complex diseases clinical researchers have ever studied. Just as the brain is complicated, the disease is complicated. Current treatments for Alzheimer’s only help to slow the worsening of symptoms, such as memory loss and confusion, and improve the quality of life for those with the disease and their family or caregivers. There are no current medicines that treat the underlying cause of the disease. However, clinical researchers are going boldly in their efforts, seeking to pinpoint what causes Alzheimer’s and working to develop better ways to not only treat the disease but to prevent it from developing.

Alzheimer’s disease and other dementias are estimated to cost the United States health care system over $259 billion by the end of 2017 with costs projected to increase into the trillions of dollars by 2050. The research industry is therefore racing to develop new treatments for the disease. PhRMA, an organization that supports the search for new treatments and cures for disease, reports that there are 87 potential new treatments in clinical trials regulated by the Food and Drug Administration for Alzheimer’s disease. Researchers are currently focusing on developing treatments that, for example, target the immune system to enable it to fight the disease or help to lower inflammation in the brain, which has been found to be associated with Alzheimer’s disease.  

 “For years, research has been focusing on the symptoms of Alzheimer’s disease. We are on the edge of discovering the root cause of this terrible illness. Investing in research now will cost our nation far less than the cost of care for the rising number of Americans who will be affected by Alzheimer’s in the coming decades.” – Dr. Thomas Ledbetter, Medical Director at ClinPoint Trials

The number of new treatments being studied in clinical trials for Alzheimer’s will continue to rise as we learn more about the science of the disease. Since 1998, here have been 123 potential treatments halted in clinical trials while only four treatments were approved by the U.S. Food and Drug Administration. Despite the frustration of these setbacks, the knowledge gained about the disease and about what treatments show promise versus those that don’t is critical to the advancement of medicine for Alzheimer’s.

 “The number of treatments in the research pipeline for Alzheimer’s alone is hope enough that there will one day be a cure for the disease. It is exciting to consider that our very own neighbors may soon be able to have an opportunity to take part in finding a cure by participating in clinical trials for Alzheimer’s disease.” – Sherry Johnson, BSN, Site Director and Research Nurse at ClinPoint Trials

It is crucial for all of us, as we all know individuals affected by Alzheimer’s, to keep watch of opportunities to participate in clinical trials for the disease. ClinPoint Trials hopes to provide these opportunities to participate in finding the cure for Alzheimer’s to individuals in the Ellis County and surrounding areas in the near future.

November is National Alzheimer’s Disease Awareness Month. Visit www.alz.org and www.PhRMA.org to learn more.

Learn more about ClinPoint and opportunities to participate in clinical trials at www.cptrials.com.

Hitting the Mark in Migraines

By: Marisa Sibley, CCRC

Originally published in the July/August 2017 Issue of Ellis County Living Magazine

I met Laura for the first time in the summer of 2015. She came to my office for her first visit as a volunteer for a clinical research study for migraine headaches. “How are you today?” I asked. “Not great,” she said. “I’ve had a migraine for three days. None of the medications I have used have helped my pain.” As we continued to discuss her condition, she informed me that she experienced a migraine headache nearly 20 days each month. Her condition was debilitating. It hindered her ability to work, to enjoy quality time with her family, and to perform normal, day-to-day tasks.

Laura was far from alone. According to the Migraine Research Foundation, 38 million people in the U.S. suffer from migraine headaches, with three times as many women experiencing symptoms than men. Migraine headaches are more severe than typical headaches. Besides being associated with costly healthcare, the condition also takes an economic toll, costing the U.S. an estimated $13 billion annually. During a migraine attack, an individual experiences pain that throbs or pulses, usually on one side of the head. They typically cause individuals to have sensitivities to lights and sounds, and may even cause blocked vision or dizziness. In addition to the pain, moderate to severe nausea and vomiting are common.  

There are several different over the counter and prescription medications that are approved by the U.S. Food and Drug Administration (FDA) for use by individuals with migraines. These may include non-steroidal anti-inflammatory drugs (NSAIDS), triptans, or other non-migraine treatments. Despite their common use, these treatments are only designed to treat pain after symptoms of a migraine start.

Investigational new treatments that block calcitonin gene-related peptide (CGRP), a protein found in the body to be in high levels during inflammation, are making their way towards likely FDA approval for the treatment of migraine headaches. Treatments of this class are being developed to stop migraines before symptoms start. In clinical trials, these treatments have shown to have positive safety profiles and be effective in reducing the number of days each month an individual experiences a migraine headache.

At ClinPoint Trials, we were able to work with Eli Lilly and Company and patient volunteers from the community on a clinical trial for a treatment called galcunezumab, a CGRP antibody developed to prevent migraine headaches. In a recent press release, Eli Lilly revealed positive results in Phase 3 clinical trials for patients who experienced migraine headaches. These studies compared galcunezumab to placebo, an inactive substance. While the treatment did not completely stop patients from experiencing migraines, those that received it did experience significantly fewer headaches per month compared to patients that received placebo.

“Migraine prevention will be significantly improved with the emergence of treatments such as galcunezumab,” says Dr. Thomas Ledbetter, Principal Investigator at ClinPoint Trials. “While we were blinded to what treatment group the patients were assigned, we had several patients in this study who were so excited to have their migraines finally under control after years of suffering using traditional therapies.”

There is indeed hope for people like Laura that live with migraine headaches and cannot find a treatment that works for them. While it may be a few more years before we see new treatments for migraine headaches receive FDA approval and hit the market for use, we can hold onto hope that we are on the edge of a breakthrough.

From the Lab to Your Medicine Cabinet

Understanding Clinical Trials and the Purpose in Participation

By: Marisa Sibley

Originally published in the May/June 2017 issue of Ellis County LIVING Magazine

When I was a child, I struggled with asthma. To help my condition, my doctor gave me an inhaler that contained a preventative asthma medication. It was easy to use and it helped make physical activities easier for me. I was able to play my favorite sports without fearing I wouldn't be able to breathe. This helped give me a better quality of life as a child. I no longer struggle with asthma, but I am thankful that there was a treatment available to help my condition. 

For me it was an asthma medication and in inhaler. For some it may be insulin or a blood sugar monitor. For others it may simply be an over the counter medication for a common cold or a headache. 

All medications of medical devices available for use by the general population are so only because of individuals who were first willing to volunteer to participate in clinical trials. 

Clinical trials are research studies that seek to answer questions about medical treatments, medical devices or medical strategies. All medical treatments and devices start as ideas. Those ideas are then developed and tested in the laboratory. If the research on these new developments is promising and the Food and Drug Administration (FDA) approves further research testing, then the idea may move forward into clinical trials with human volunteers. 

All potential treatments and devices are tested first in Phase 1 trials, which will only assess whether or not the products are safe for human use. If the products show to be generally safe, then the treatments or devices will continue into Phase 2 and 3 trials with larger numbers of volunteers. These trials continue to answer questions about safety, but also begin to assess how well a product works to improve patient outcomes, if it will benefit a patient, or if the product causes unexpected harm. The FDA monitors and reviews the research data on investigational treatments and devices very closely during all phases of clinical trials and can stop the trials at any time. 

After all trials are completed, the FDA may or may not decide to approve a new treatment or device. Only after FDA approval will these ideas turned treatments end up in our medicine cabinets. Research then continues on these treatments or devices after they enter the marketplace. 

There are many reasons why people choose to participate in clinical trials The top reasons include to advance medicine, to help improve the lives of others, to help improve their own medical condition or to supplement their own standard health care. 

If you choose to join a clinical trial, you can expect to first be thoroughly informed about the study, what the study is testing, information about study appointments and procedures, potential risks and benefits, and your role as a participant.The study doctor, also called an Investigator, will assess whether or not you would be eligible to participate in the study. your eligibility may depend on your medical history, medications you are taking, or other diagnostic tests or exams. 

Throughout the course of your participation in a trial, you can expect your health to be monitored very closely by the Investigator and the study team. This is done through a series of visits to the clinical research site before, during and after a study treatment or device is received or used. Since you are a volunteer, your study-related care is provided free of charge. You may also receive compensation for your time and travel. 

Had no one ever participated in clinical trials for asthma, I may not have had access to a medication that helped my condition improve as a child. Clinical trials are the gateway to advancing medical knowledge and patient care for generations to come. Whether you are a healthy person or have a chronic medical condition, you can help to move medicine forward through participation in a clinical trial. It is truly a gift that keeps on giving. 

If you are interested in participating in a clinical trial in the future or would like more information, reach out to your local clinical research site to speak with a member of the study team about how you can get involved. 

Learn more at www.cptrials.com. You can reach her at (972) 937-1640 or marisas@cptrials.com for more information.

Holiday Highlight

The Christmas season is all about giving.

One of our favorite things about being a part of the Ellis County and Waxahachie community is the willingness of individuals and organizations to offer support to it's fellow neighbors.

Each year, ClinPoint selects a local organization or support service to assist with their missions. We were recently introduced to a local organization called Believing Restoration is Attainable (BRA). Their mission is to "support the ladies" by offering support services to women who are experiencing grief or trauma. These services range from recovery programs like GriefShare and DivorceCare to providing life skills training, professional counseling and transitional services to those that are in need of them. 

The organization hosts an annual holiday party for it's members and their children. Santa makes an appearance and those that attend enjoy a meal and community together. A couple of our staff members were able to attend the event and drop off some goodies for the members of the organization and their families. 

We appreciate this organization's service to the women of Ellis County and Waxahachie, and wish them the best in their vision and mission.

Learn more about Believing Restoration is Attainable here. Follow them on Facebook here

Pictured above:

Members of Believing Restoration is Attainable (BRA) with Sherry Johnson, ClinPoint Trials Owner and Site Director, and Kristen Johnson, Lead Medical Technologist.

Sherry Johnson and BRA Founder Sharon Verigan.

A Word on Diabetes

Originally published in the ClinPoint Trials November Newsletter – Subscribe here.

According to the American Diabetes Association, diabetes mellitus affects nearly 30 million children and adults in the United States. Another 86 million Americans have pre-diabetes and are at risk for developing type 2 diabetes. For a condition that is so common, many still ask…

What is Diabetes Mellitus?

Diabetes mellitus refers to what is actually a group of diseases that affect how your body processes blood sugar, also known as glucose. Glucose is the brain’s main source of fuel and a very important source of energy for the cells that the body is made up of.

There are several types of diabetes mellitus, including type 1 and 2, pre-diabetes or gestational diabetes. One important factor involved in diabetes mellitus, regardless of the type, is insulin. Insulin is a hormone produced by the pancreas that regulates the amount of glucose allowed to enter the cells of the body. Although the variable types of diabetes mellitus may have different causes, the nature of the diseases is the same; there is too much glucose in the bloodstream, which can lead to serious health problems if not adequately controlled.

Pre-diabetes and Gestational Diabetes

Pre-diabetes is a condition in which blood sugar levels are higher than normal, but not yet high enough for a diagnosis of type 2 diabetes. Gestational diabetes occurs during pregnancy and can be passed onto the newborn baby.

Type 1 Diabetes

In type 1 diabetes, the immune system attacks the cells that produce insulin in the pancreas. In turn, your body is left with little or no insulin, allowing glucose to build up in the bloodstream. The cause of type 1 diabetes is unknown but is thought to be contributed to genetic and environmental factors. Type 1 diabetes appears most often in childhood and is treated primarily by insulin injections.

Type 2 Diabetes

In type 2 diabetes, the cells of the body become resistant to insulin. The pancreas becomes unable to produce enough insulin to overcome the resistance. Therefore, glucose builds up in the bloodstream instead of moving into the cells of the body to be used for energy. The cause of type 2 diabetes is not clearly known, but similar to type 1, genetic and environmental factors are thought to be contributors to the development of the disease. Type 2 diabetes appears most often in adults over the age of 40, although it can develop in younger individuals. It is treated by primarily by monitoring blood sugar, oral medications, insulin injections or both.

Risk Factors

There are several risk factors for the different types of diabetes mellitus. An individual is at an increased risk for developing type 1 diabetes if a parent or sibling has the disease, if there Is a presence of damaging immune system cells, called autoantibodies, or if one is not consuming enough vitamin D. Type 1 diabetes is the only type of disease that cannot be prevented. However, it is often encouraged for individuals to follow similar lifestyle habits of those working to control the other types of diabetes mellitus.

Risk factors for pre-diabetes and type 2 diabetes include excess weight, a sedentary lifestyle, family history, being of African American or Hispanic race, increased age, poor eating habits especially including increased intake of refined carbohydrates and refined sugars, having gestational diabetes while pregnancy and other medical conditions such as PCOS, high blood pressure or high cholesterol or triglycerides.

Gestational diabetes can be developed in any woman that is pregnant, but some women are more at risk than others. Risk factors include increased age, family or person history, being overweight or being of African American or Hispanic race.


Symptoms of diabetes can include increased thirst, frequent urination, extreme hunger, fatigue and irritability, blurred vision or presence of ketones in the urine. If you feel you are experiencing symptoms or feel you may be at risk for diabetes, you should see your doctor. He or she will be able to perform the necessary tests for diagnosis of diabetes mellitus or be able to tell you if you are indeed at risk.

Here is the good news!

Type 2 diabetes and gestational diabetes can be prevented. If you have already been diagnosed, the disease can be reversed. The best prevention measure to take if you are at risk or if you have been diagnosed with diabetes is to embrace healthy eating habits. A healthy diet for anyone is one with increased intake of fruits, vegetables, lean proteins, whole grains and legumes and limited intake of refined carbohydrates (think white bread) and refined sugars (think cookies, cakes and processed foods).  Another prevention measure is making physical activity a part of your daily routine. Exercise helps to lower blood sugar levels by moving sugar into the cells of the body where they are used for fuel. Exercise also increases sensitivity to insulin. Choose activities that you enjoy such as walking, yoga, strength training or dance classes. Both a healthy diet and physical activity can promote the loss of excess weight. If you are overweight, losing even just 7 percent of your body weight can reduce the risk of diabetes and other health conditions.

Remember – it’s not about perfection. Small changes can produce big results!