Clinical trial NCT06571487: Growth Hormone Resistance of Beta-cells
Official title: Growth Hormone Resistance of Beta-cells in Women With Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Obesity
Healthy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of obese women ages 18-45 with and without a history of gestational diabetes mellitus.

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 and type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Singleton, full term pregnancy within the past 5 years
* Hemoglobin HbA1c ≤5.6% and fasting blood glucose \<100 mg/dl
* Body mass index ≥30.0 kg/m2 and \<45.0 kg/m2, because the majority of women with GDM have overweight/obesity

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 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 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

Primary outcomes:
measure: Beta-cell function
timeFrame: 15, 30, 60, 120, 240, and 360 min and 7 days after rhGH administration
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bettina Mittendorfer, PhD
role: PRINCIPAL_INVESTIGATOR
References: