Growth Hormone Resistance of Beta-cells

NCT07581860 | Not Yet Recruiting

• 1 other identifier: 2111127-C
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy; Obesity & Overweight; Impaired Fasting Glucose (IFG); Impaired Glucose Tolerance (Prediabetes)

Outcome Measures

Primary Outcomes (1)

• Beta-cell function

  Insulin secretion rate in relationship to plasma glucose

  before and 7 days after rhGH administration

Study Arms (2)

Impaired fasting glucose

Impaired glucose tolerance

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri School of Medicine

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Bettina Mittendorfer

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

573-884-6852; ahmc4@health.missouri.edu

Vasavi Shabrish

CONTACT

v.shabrish@missouri.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5 years after completion of the study

Locations

US (1)