Infant Formula for Fussy Babies (Closed)

IS YOUR BABY FUSSY?

ClinPoint Trials is seeking fussy, formula-fed infants for a research study.This is a study for a commercially available infant formula intended for full-term infants 0-12 months of age.

If your infant is formula-fed and fussy, he/she may be eligible to participate. 

To qualify to participate in this study, your infant must be:

  • Healthy

  • Formula-fed

  • Fussy

  • Full-term at birth (not premature)

  • 14-60 days old

  • Not on any medications

For more information or to see if your infant is eligible to participate in this study, please contact ClinPoint Trials at (972) 937-1640

Principal Investigator: Peggy Linguist, M.D.

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.


Marisa is the Lead Clinical Research Coordinator at ClinPoint Trials, a clinical research site in Waxahachie. Learn more about ClinPoint and opportunities to participate in clinical trials at www.cptrials.com.

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.

Marisa is the Lead Clinical Research Coordinator at ClinPoint Trials, a clinical research site in Waxahachie. 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. 


Marisa is a Certified Clinical Research Coordinator (CCRC) at ClinPoint Trials, a clinical research site in Waxahachie. Learn more at www.cptrials.com. You can reach her at (972) 937-1640 or marisas@cptrials.com for more information.

Type 2 Diabetes (Closed)

ClinPoint Trials is seeking adults who have been diagnosed with Type 2 Diabetes for a clinical research study. 

You may be eligible for this study if you are currently taking Metformin. 

Throughout the course of the study, your health will be monitored by the study team and the study doctor. Qualified participants will receive study-related physical exams, lab tests, and investigational study medication or placebo at no cost.

Compensation may be provided for time and travel.

Contact us at (972) 937-1640 for more information.

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

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!