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NCT05724134 · ClinicalTrials.gov registry record · Phase 1
Pancreatic Clamp in NAFLD
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT05724134 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 18 participants.
The verdict
NCT05724134, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.
Interventions
- DRUG Glucagon
- DRUG Octreotide Acetate
- DRUG Insulin human
- DRUG Growth Hormone, Human
- OTHER [6,6-2H2] D-glucose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-08-29 |
| Est. Completion | 2025-09-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05724134
The ClinicalTrials.gov registry entry for NCT05724134 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Glucagon is the first listed.
NCT05724134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05724134 about?
NCT05724134 is a clinical study titled "Pancreatic Clamp in NAFLD". This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of over...
What is the current status of trial NCT05724134?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-08-29. Estimated completion is 2025-09-24.
What interventions are being tested in trial NCT05724134?
The interventions under investigation include: Glucagon (DRUG), Octreotide Acetate (DRUG), Insulin human (DRUG), Growth Hormone, Human (DRUG), [6,6-2H2] D-glucose (OTHER).
Who is sponsoring clinical trial NCT05724134?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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