Growth Hormone Resistance of Beta-cells in People With a Family History of Type 2 Diabetes

NCT06571500 | Recruiting

• 1 other identifier: 2111127-B
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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 type 2 diabetes.

Conditions

Healthy; Obesity

Outcome Measures

Primary Outcomes (1)

• Beta-cell function

  Insulin secretion rate in relationship to plasma glucose

  before and 7 days after rhGH administration

Study Arms (2)

Men and women with a family history of type 2 diabetes

Men and women without a family history of type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of obese men and women ages 18-45 with and without a first degree relative with type 2 diabetes.

You may qualify if:

• to 59 years old
• body mass index ≥30.0 kg/m2 and \<45.0 kg/m2
• Family history of type 2 diabetes: first degree relative with type 2 diabetes
• Control group: no family history of type 2 diabetes

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri School of Medicine

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bettina Mittendorfer, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Heider

CONTACT

573-884-6852; ahmc4@health.missouri.edu

Vasavi Shabrish, PhD

CONTACT

v.shabrish@missouri.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: July 15, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5 years after completion of the study

Locations

US (1)