Join Clinical Trials for Diabetes (Type 2)
Type 2 Diabetes
Diabetes refers to a chronic condition that impairs the way an individual’s body metabolizes its main source of fuel – glucose (i.e., “blood sugar”). Type 2 diabetes develops when the body becomes resistant to the effects of insulin (a hormone produced by the pancreas that regulates the amount of glucose in the blood), or when it fails to produce sufficient amounts of insulin to maintain normal blood glucose levels.
If left untreated, type 2 diabetes can be fatal. No one knows for certain why type 2 diabetes occurs, but excess body weight and physical inactivity are known to be associated with its onset.
Other risk factors associated with type 2 diabetes include family history of the disease, race and ethnicity (African Americans, Hispanics, American Indians, and Asian-Americans are more likely to develop type 2 diabetes than whites), and increasing age.
In addition, individuals who have a condition known as prediabetes, in which blood sugar is elevated but not high enough to be diagnosed as type 2 diabetes, also face an increased risk of diabetes, as prediabetes can progress into type 2 if not properly treated.
Finally, women who develop diabetes during pregnancy (gestational diabetes) also have an increased risk of developing type 2 diabetes later in life.
For most people, type 2 diabetes can be successfully managed through thoughtful and diligent lifestyle modifications that include dietary and activity-related changes. For some, medication may also be needed to supplement behavioral modifications.
Nevertheless, type 2 diabetes still carries with it the risk of long-term complications, many of which can develop gradually over long periods of time. These complications include cardiovascular disease, damage to the nerves, kidneys, eyes, feet, and skin. Furthermore, type 2 diabetes can lead to the development of gum infections and osteoporosis. Some research suggests that it may also increase the risk of developing Alzheimer’s disease and other forms of dementia.
If you are one of the nearly 20 million people in the United States who have been diagnosed with diabetes, you may be seeking out a clinical trial in the hope of finding a better means of managing your disease, minimizing complications, or simply to contribute to the overall research effort.
The diabetes research industry is massive, with the U.S. government spending over $1 billion annually on diabetes-related research. Some of the topics currently being investigated include: more accurate methods of diagnosing diabetes; evaluating the impact of specific nutrients (such as carbohydrates) on the development, progression and treatment of type 2 diabetes; using cell-based therapies to help the body re-learn to produce insulin on its own; and investigating the relationship between type 2 diabetes and its numerous complications, in an effort to develop more effective methods of preventing them from occurring.
What Will Type 2 Diabetes Clinical Trials Be Like?
The types of tests and assessments used in type 2 diabetes clinical trials will ultimately depend on the specific nature of the study and what aspects of type 2 diabetes are being investigated. Provided below is a list of frequent procedures and tests that may be incorporated for use in clinical trials:
- Physical exam
- Glycated hemoglobin test (A1C test): a blood test that indicates an individual’s average blood sugar level over the prior two months.
- Random, standard blood sugar tests that measure the amount of glucose in the blood at a particular point in time.
- Fasting blood sugar tests that measure blood sugar levels following an overnight fast.
- Oral glucose tolerance tests: this test involves overnight fasting, followed by a fasting blood sugar test, then consumption of a sugary liquid. Blood sugar levels are then tested periodically over the following few hours.
- Blood tests to monitor cholesterol levels.
- Nerve conduction tests to monitor the health of nerves, especially in the feet.
- Eye tests
- Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
- Pain and quality of life assessments, as well as food and/or exercise diaries, may also be required in some studies, depending on the research question being studied.
Typical Type 2 Diabetes Clinical Trial Protocol:
Specific examples of clinical trials for type 2 diabetes might include the following:
- A randomized study to determine if a commercial weight-loss program modified for use by individuals with type 2 diabetes leads to greater improvements in blood glucose control when compared to a control group of patients with type 2 diabetes who receive standard diabetes counseling.
- A randomized clinical trial in which obese subjects with type 2 diabetes are randomly assigned to receive treatment with a newly-develop drug designed to help the body produce more insulin, or to receive a placebo. Such a study would evaluate the safety and tolerability of the new drug as measured by the number of adverse side effects experienced by subjects in each group.
- A study designed to evaluate the safety and effectiveness of two weight loss surgeries for morbidly obese individuals with type 2 diabetes, compared to a group of morbidly obese subjects with type 2 diabetes who receive intensive lifestyle modification therapy. Subjects in this study would be followed over a two-year period to compare the effects of these three treatments on their type 2 diabetes.
- A study in which 8th grade students at 20 middle schools receive an intervention that integrates type 2 diabetes prevention education through four means: the school nutrition environment, physical education department, behavior change initiatives, and educational activities. The purpose of this study would be to determine if, over the course of a school year, participating students showed improvements in their body mass index (a measure of body composition), fasting glucose, and fasting insulin levels.
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment (such as the first example listed above).
On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.
Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.
In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time (such as the second example provided above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.
It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.
It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.
Trial Eligibility and Medical Information Needed:
The type of clinical trial you may be eligible for often depends on many factors, including your history of diabetes, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:
- Your most recent A1C measurement
- Your family history of diabetes
- Your prior history of treatment for diabetes and other medical conditions (including any surgeries, procedures, and medications)
- Your current medications (including aspirin), vitamins, and dietary supplements
- Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels (if known)
Suggested Search Terms:
“type 2 diabetes children,” “type 2 diabetes therapy,” “type 2 diabetes treatment,” “type 2 diabetes obesity,” “type 2 diabetes exercise,” “type 2 diabetes complications,” “type 2 diabetes management,” “type 2 diabetes genetics,” and “type 2 diabetes prevention.”
Current Search Term:
“Diabetes (Type 2)”