Growth Hormone Resistance of Beta-cells A

NCT06571487 | Recruiting

• 1 other identifier: 2111127-A
• 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 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.

Conditions

Gestational Diabetes; Obesity; Healthy

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)

Women with a history of gestational diabetes mellitus

Women without a history of gestational diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of women ages 18-45 with and without a history of gestational diabetes mellitus.

You may qualify if:

• Singleton, full term pregnancy within the past 5 years
• Body mass index ≥18.5 kg/m2 and \<45.0 kg/m2
• Gestational Diabetes Group: History of gestational diabetes in the most recent pregnancy
• Control Group: no history of gestational 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 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

Diabetes, Gestational; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; 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: October 22, 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)