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Not yet recruiting NCT07581860

Growth Hormone Resistance of Beta-cells

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy, Obesity & Overweight, Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (Prediabetes). Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Growth Hormone Resistance of Beta-cells in People With Impaired Fasting Glucose vs Impaired Glucose Tolerance

Overview

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.

Primary outcome measures

  • Beta-cell function [Time frame: before and 7 days after rhGH administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Missouri School of Medicine — Columbia

Identifiers

NCT: NCT07581860 · 2111127-C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗