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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: Completed Phase 1 study, sponsored by Columbia University.
NCT05724134 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Goal is first to clamp insulin infusion rate to maintain mean basal fasting plasma glucose during the basal titration phase, and then during the intervention phase to observe the glucose levels that result from altering the basal 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 |
What the finished NCT05724134 record still lists
NCT05724134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Glucagon is the first listed.
NCT05724134 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05724134's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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