Growth Hormone Resistance of Beta-cells in Women and People

NCT ID: NCT06571500

Last Updated: 2025-07-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-15

Study Completion Date

2030-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 family history of type 2 diabetes at the University of Missouri. Our aim is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Men and women with a family history of type 2 diabetes

No interventions assigned to this group

Men and women without a family history of type 2 diabetes

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 to 45 years old
* hemoglobin HbA1c ≤5.6% and fasting blood glucose \<100 mg/dl
* body mass index ≥30.0 kg/m2 and \<45.0 kg/m2


* Family history of type 2 diabetes: first degree relative with type 2 diabetes
* Control group: no family history of type 2 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 type 1 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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bettina Mittendorfer

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bettina Mittendorfer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Missouri School of Medicine

Columbia, Missouri, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amanda Heider

Role: CONTACT

573-884-6852

Vasavi Shabrish, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bettina Mittendorfer

Role: primary

573-882-9377

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2111127-B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.