Growth Hormone Resistance of Beta-cells A
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes, Obesity, Healthy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Growth Hormone Resistance of Beta-cells in Women With Gestational Diabetes Mellitus
Overview
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.
Primary outcome measures
- Beta-cell function [Time frame: before and 7 days after rhGH administration]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Missouri School of Medicine — Columbia
Identifiers
NCT: NCT06571487 · 2111127-A