Recruiting

Growth Hormone Resistance

Sponsor:

University of Missouri-Columbia

Code:

NCT06571487

Conditions

Gestational Diabetes

Obesity

Healthy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06571487

Start date

Oct 22, 2025

Status verified date

Apr, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Women with a history of gestational diabetes mellitus

Women without a history of gestational diabetes mellitus

Primary outcome measure

  • Beta-cell function [ Time Frame: before and 7 days after rhGH administration ]

Central Contacts and Locations

Central contacts

Amanda Heider

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

Vasavi Shabrish, PhD

v.shabrish@missouri.edu

Locations

University of Missouri School of Medicine

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Bettina Mittendorfer

573-882-9377b.mittendorfer@missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

May 11, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-05-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.