- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581860
Growth Hormone Resistance of Beta-cells (GHRB-C)
May 5, 2026 updated by: Bettina Mittendorfer, University of Missouri-Columbia
Growth Hormone Resistance of Beta-cells in People With Impaired Fasting Glucose vs Impaired Glucose Tolerance
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 impaired fasting glucose or impaired glucose tolerance 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 type 2 diabetes.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vasavi Shabrish
- Email: v.shabrish@missouri.edu
Study Contact Backup
- Name: Study coordinator
- Phone Number: 573-884-6852
- Email: ahmc4@health.missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- University of Missouri School of Medicine
-
Contact:
- Study coordinator
- Phone Number: 573-884-6852
- Email: ahmc4@health.missouri.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of lean and obese people ages 18-59 with impaired fasting glucose or impaired glucose tolerance.
Description
Inclusion Criteria:
- body mass index >18.5kg/m2 and <45.9kg/m2
- impaired fasting glucose >/= 100mg/dL, </= 126mg/dL or impaired glucose tolerance on 75g oral glucose tolerance test (blood glucose 140 to 199mg/dL at two-hours)
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 type 1 diabetes
- evidence of 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Impaired fasting glucose
|
|
Impaired glucose tolerance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beta-cell function
Time Frame: before and 7 days after rhGH administration
|
Insulin secretion rate in relationship to plasma glucose
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before and 7 days after rhGH administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bettina Mittendorfer, University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2030
Study Registration Dates
First Submitted
May 5, 2026
First Submitted That Met QC Criteria
May 5, 2026
First Posted (Actual)
May 12, 2026
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 5, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Hyperglycemia
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Prediabetic State
- Glucose Intolerance
Other Study ID Numbers
- 2111127-C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be available upon reasonable request
IPD Sharing Time Frame
5 years after completion of the study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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