Join Clinical Trials for Diabetes In Pregnancy
Diabetes in Pregnancy (Gestational Diabetes)
The female body undergoes numerous changes during pregnancy. Unfortunately, some of them may not always be welcome, and some may even be dangerous to both mother and baby. Gestational diabetes is one such example.
Simply speaking, gestational diabetes refers to diabetes that first occurs, or is first diagnosed, during pregnancy. Gestational diabetes occurs as a result of the increased production of pregnancy-related hormones, which can prevent insulin from performing its job of regulating blood glucose levels.
There are a number of risk factors for the development of gestational diabetes, including age greater than 25, a family history of diabetes, prior birth of a baby weighing more than nine pounds, high blood pressure, the presence of too much amniotic fluid, and being overweight prior to the pregnancy.
Gestational diabetes is usually asymptomatic, though symptoms can occur and include blurred vision, fatigue, frequent infections, increased urination, nausea, and weight loss. It typically arises half-way through the pregnancy, and usually resolves on its own following delivery of the baby.
Once diagnosed, however, women with gestational diabetes must carefully monitor their blood sugar levels to ensure that they remain within normal limits. Their healthcare provider will also monitor their baby at regular intervals to check the baby’s size and overall health.
Current research related to gestational diabetes is investigating the long-term effects of the condition on both mothers and their children, refining diagnostic methods to more accurately and timely diagnose the condition during pregnancy, evaluating the use of medications to prevent the development of gestational diabetes among high-risk women, and comparing and testing new methods of treating the condition.
What Will Gestational Diabetes Clinical Trials Be Like?
The types of tests and assessments used in gestational diabetes clinical trials will ultimately depend on the specific nature of the study and what aspects of gestational 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
- Pelvic exam
- Abdominal or vaginal ultrasound
- 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 and/or hormone levels.
- Nonstress test: this test involves monitoring the baby’s heartbeat using an electronic fetal monitor placed on the mother’s abdomen.
- 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.
- Dietary and/or exercise interventions
- 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 Gestational Diabetes Clinical Trial Protocol:
Specific examples of clinical trials for gestational diabetes might include the following:
- A randomized study to determine if a lifestyle intervention consisting of monthly in-person educational sessions and biweekly telephone calls are effective at improving glucose control among overweight Hispanic women with an increased risk for gestational diabetes. In such a study, participants would be randomized to receive the educational intervention or standard care.
- A randomized clinical trial in which women with gestational diabetes are randomized to receive treatment with a glucose-control medication (metformin) or insulin injections, to determine which is more effective at controlling blood glucose levels.
- An observational study that utilizes focus groups to interview women with gestational diabetes who are at an increased risk of developing type 2 diabetes following delivery for the purposes of refining a diabetes prevention program geared toward such women.
- A randomized clinical trial in which obese pregnant women are randomized to receive either a supervised, in-home cycling-based exercise intervention (three times per week) or standard prenatal care. The purposes of such a study would be to determine if the exercise intervention is more successful at preventing the development of gestational diabetes versus standard care.
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 and fourth examples 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, 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 gestational diabetes, treatment history, stage of pregnancy, 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 current gestational week of pregnancy
- 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:
“gestational diabetes treatment,” “gestational diabetes risk,” “gestational diabetes prevention,” “gestational diabetes screening,” “gestational diabetes management,” “gestational diabetes childhood,” “gestational diabetes exercise,” “gestational diabetes diet,” and “gestational diabetes genetics.”
Current Search Term:
“Diabetes In Pregnancy”