Growth Hormone Resistance of Beta-cells

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how certain cells in the pancreas, called beta-cells, respond to growth hormone in women who have had gestational diabetes, which is high blood sugar during pregnancy. The researchers at the University of Missouri want to learn more about how growth hormone affects these cells and how it might relate to developing gestational diabetes and type 2 diabetes later in life.

To participate in this study, you need to be a woman between the ages of 18 and 45 who had a full-term pregnancy within the last five years and has either had gestational diabetes in that pregnancy or no history of it at all. You should also have a body mass index (BMI) between 30 and 45, as many women with gestational diabetes are overweight or obese. Participants can expect to undergo tests that will help the researchers gather important information about how your body functions with growth hormone. It’s important to know that certain conditions or medications may make you ineligible to join, so be sure to discuss any health issues with the study team.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Singleton, full term pregnancy within the past 5 years
• • Hemoglobin HbA1c ≤5.6% and fasting blood glucose \<100 mg/dl
• • Body mass index ≥30.0 kg/m2 and \<45.0 kg/m2, because the majority of women with GDM have overweight/obesity
• Group specific inclusion criteria:
• • Gestational Diabetes Group: History of gestational diabetes in the most recent pregnancy
• • Control Group: no history of gestational diabetes
• Exclusion Criteria:
• • Pregnant, planning to become pregnant during the study, or breastfeeding
• • Current diagnosis or history of type 1 or type 2 diabetes
• • Use of medications that can impact the study outcomes (e.g., GLP-1 receptor agonists)
• • History of bariatric surgery
• • Known hypothyroidism or use of thyroid medications
• • History of intracranial hypertension, including papilledema, or a condition that increases the risk of developing intracranial hypertension, such as Turner Syndrome, Prader-Willi Syndrome, or renal impairment
• • Current cancer or cancer that has been in remission less than 5 years
• • First degree relative with diabetes diagnosis
• • Evidence of significant anemia or significant end organ dysfunction (e.g., liver, kidney, heart disease)
• • Alcohol use disorder, use of controlled substances, or smoking \>2 cigarettes per day
• • Greater than 3% weight loss within three months of screening or engaged in regular (≥3 days per week), continuous moderate- or high-intensity exercise of ≥30 min duration
• • Mentally disabled persons, prisoners, and persons with inability to grant voluntary informed consent