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.

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.

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!