Growth Hormone Resistance of Beta-cells

Recruiting

• Conditions: Healthy; Gestational Diabetes; Obesity

• Registration Number: NCT06571487
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a personal history of gestational diabetes (high blood sugar in pregnancy) at the University of Missouri. The aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-01
• Primary Completion: 2028-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Beta-cell function	15, 30, 60, 120, 240, and 360 min and 7 days after rhGH administration	Insulin secretion rate in relationship to plasma glucose

Trial Locations

Locations (1)

University of Missouri School of Medicine; 🇺🇸 Columbia, Missouri, United States