Growth Hormone Resistance of Beta-cells

NCT ID: NCT06571487

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-22

Study Completion Date

2030-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Obesity Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with a history of gestational diabetes mellitus

No interventions assigned to this group

Women without a history of gestational diabetes mellitus

No interventions assigned to this group

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Bettina Mittendorfer

Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bettina Mittendorfer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri School of Medicine

Columbia, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda Heider

Role: CONTACT

Phone: 573-884-6852

Email: [email protected]

Vasavi Shabrish, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Bettina Mittendorfer

Role: primary

Other Identifiers

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2111127-A

Identifier Type: -

Identifier Source: org_study_id