Growth Hormone Resistance of Beta-cells in Women and People (GHRB-B)

University of Missouri (MU)

Status: Enrolling

Conditions: Healthy; Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT06571500

2111127-B

Details and patient eligibility

About

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 family history of type 2 diabetes at the University of Missouri. Our aim is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 45 years old
• hemoglobin HbA1c ≤5.6% and fasting blood glucose <100 mg/dl
• body mass index ≥30.0 kg/m2 and <45.0 kg/m2

Additional, group-specific inclusion criteria:

• Family history of type 2 diabetes: first degree relative with type 2 diabetes
• Control group: no family history of type 2 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 type 1 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

Trial design

30 participants in 2 patient groups

Men and women with a family history of type 2 diabetes

Men and women without a family history of type 2 diabetes