Understanding how growth hormone affects insulin-producing cells in women with gestational diabetes
Growth Hormone Resistance of Beta-cells in Women With Gestational Diabetes Mellitus
This study looks at how growth hormone affects insulin-producing cells in women who had gestational diabetes compared to those who didn't, to see if it helps us understand their risk for type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT06571487 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the response of beta-cells in the pancreas to growth hormone in individuals with a history of gestational diabetes. Conducted at the University of Missouri, the research focuses on understanding the relationship between growth hormone and the risk factors for developing gestational diabetes and type 2 diabetes. Participants will be categorized into two groups: those with a history of gestational diabetes and a control group without such a history. The study will analyze how these groups differ in their beta-cell function and insulin regulation.
Who should consider this trial
Good fit: Ideal candidates include women who have had a singleton, full-term pregnancy within the past five years and have a history of gestational diabetes or are otherwise healthy with specific BMI criteria.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a history of type 1 or type 2 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of gestational diabetes and its long-term implications for type 2 diabetes.
How similar studies have performed: While there is ongoing research into the effects of growth hormone on insulin regulation, this specific focus on beta-cells in the context of gestational diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton, full term pregnancy within the past 5 years * Body mass index ≥18.5 kg/m2 and \<45.0 kg/m2 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, uncontrolled hypothyroidism * 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
Where this trial is running
Columbia, Missouri
- University of Missouri School of Medicine — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Bettina Mittendorfer, PhD — University of Missouri-Columbia
- Study coordinator: Amanda Heider
- Email: ahmc4@health.missouri.edu
- Phone: 573-884-6852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.