Clinical Trials

Clinical trials are research studies that focus on very specific issues with regards to diabetes. These can include diabetes in combination with other existing health conditions or on new types of medications, treatment options, lifestyle changes, diets, exercise programs or literally any other type of issue related to the disease.

Clinical trials may provide compensation to participants to help defer the cost of participating in the study. This may include the cost of medications, compensation for specific trainings, lost wages for days away from work, travel and transportation costs or a flat amount payment. Many medical research trials don’t offer financial compensation per se, but they do provide free medical tests and medications while the study is in progress.

In some situations, surgical procedures may also be covered by the study or some parts of the medical costs can be included in the study. New studies on the use of gastric bypass or weight loss surgery and diabetes have been very prominent in clinical trials and studies. Other studies have focused on lifestyle choices such as smoking, specific eating patterns, or environmental aspects that are attributed to the development of type 2 diabetes, gestational diabetes and prediabetes.

How To Find Clinical Trials

One of the best ways to access current sources of information on clinical trials is talking directly to your doctor. If you are seeing a specialist for your diabetes or associated health concerns, that specialist is also an excellent source of information. Often people with diabetic neuropathy, cardiovascular disease, diabetic retinopathy, kidney dysfunction or other types of health concerns are required in long term and shorter duration studies.

Another source of information about clinical trials on diabetes is the American Diabetes Association. The information on their website can be helpful in finding clinical trials in your area, then discussing the possibility of your participation with your physician. The clinical trials will often list very specific criteria for participation. The criteria can include age, gender, medications on or not on, specific health issues such as hypertension, history of cardiovascular disease, weight or diagnosed health conditions in concurrence with diabetes. Although you may seem to meet the criteria, you will not be entered into the study until after an interview has been completed. Understanding just what the purpose of the trial is and what specific questions you should ask is essential to determining if the trial is right for you. 1

Most clinical trials will require that the participants live within a specific geographic region, usually close to the clinic, hospital or research facility that is conducting the study. This is a logistic feature that ensures maximum participation for the duration of the study.  Since medical specialists are often made aware of studies in their geographic area, they are often the best source of referral. It is also very important to tell your doctor if you are participating in a clinical trial. This is true if there are any changes to your medications, exercise routine or diet that is required throughout the trial.

Types of Clinical Trials

There are many different types of clinical studies and trials. Some will require active participation on a regular basis, such as an exercise, lifestyle or diet study. Other research studies may require participating in group or one-on-one counseling or completing surveys and relevant questionnaires. Still other studies may include participating in drug studies or specific types of medical treatments.

Drug studies are usually comprised of a study group and a control group. The control group is usually provided with a placebo, which contains no active drugs or medications, or the standard treatment to compare with the study drug. If there is a chance that a placebo will be used all participants must be informed of the fact. Participants will not be told during the study if they are getting the new medication or if they are receiving the placebo.

Randomized clinical trials are designed to prevent any bias in assigning participants to various parts of the study. Randomized trials can include medications or they can include larger studies of lifestyles, health issues, exercise or other related study parameters. Some randomized trials include filling out surveys or questionnaires and may include people’s thoughts and beliefs about diabetes. One such example was a large group study of women and children living in high poverty areas of large urban centers.

Researchers were attempting to determine if a link existed between the development of diabetes and the specific neighborhood of residency. Women were provided counseling and vouchers to help move to less poverty stricken neighborhoods, given vouchers to live in any neighborhood but no counseling or were not provided with either vouchers or counseling. The women and children were monitored for two years to include weight, height and glycated hemoglobin levels. Results found that women and children that received vouchers for lower poverty neighborhoods and counseling had a modest improvement in levels of obesity and diabetes.2

Safety And Ethics

Many people are worried about possible health risks in participating in clinical trials. However, all researchers must follow ethical principles and scientific protocols when designing and implementing a study. The clinical trials are reviewed by the research organization and an ethics board before the study can begin.

As with all new types of treatments and drug therapies, there may be a risk involved in participating in a clinical study. Researchers must disclose any possible risks and will actively screen out participants that may have health issues that would put them at risk during the study. Many of the diabetes clinical trials include medications or lifestyle choices that need to be discussed with the clinical study team as well as with your primary physician.

Commitment To The Trial

Many diabetes clinical trials are designed to track changes in weight, health, quality of life, blood glucose levels, lipid profiles, kidney functioning, neuropathy or cardiovascular health over long periods of time. These trials may last several months and may have follow-up interviews years after the original clinical trial. For example, one recently reported trial followed patients with type 2 diabetes through an exercise and diet intervention for 1 year. The results were positive for both the men and women that participated in the trial with men seeing greater improvements in fat distribution than the women. 3

Understanding the time commitment and the specific protocols you agree to over the time period of the trial is also critical. It is important to keep in mind that the information obtained from the trial will assist with better understanding of the specific focus of the study, which is a wonderful opportunity to help others and expand knowledge on this increasingly common disease.

References

1 Pre-enrollment Information. (n.d.). Retrieved from American Diabetes Association: http://www.diabetes.org/news-research/research/clinical-trials/pre-enrollment-information.html

2 Ludwig, J., Sanbonmatsu, L., Adam, E., et al. (2011). Neighborhoods, Obesity, and Diabetes — A Randomized Social Experiment. The New England Journal of Medicine , 1509-1519.

3 Albu, J. B., Heilbronn, L. K., Kelley, D. E., et al. (2010). Metabolic Changes Following a 1-Year Diet and Exercise Intervention in Patients With Type 2 Diabetes. Diabetes , 627-633.

This article was originally published July 12, 2012 and last revision and update of it was 9/10/2015.