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NCT06558422 · ClinicalTrials.gov registry record · Phase 1
Human Models of Selective Insulin Resistance: Pancreatic Clamp
A Phase 1 study, sponsored by Columbia University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT06558422 is a Phase 1 study that has not yet begun recruiting, run by Columbia University. The registered enrollment target is 36 participants.
The verdict
NCT06558422, a Phase 1 study, has not yet begun recruiting, sponsored by Columbia University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. 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 metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.
Interventions
- DRUG Glucagon
- DRUG Octreotide Acetate
- DRUG Insulin human
- DRUG Growth Hormone, Human
- DRUG 20% D-glucose (aq)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2029-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06558422
The ClinicalTrials.gov registry entry for NCT06558422 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 36 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.
NCT06558422 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06558422 about?
NCT06558422 is a clinical study titled "Human Models of Selective Insulin Resistance: Pancreatic Clamp". This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a...
What is the current status of trial NCT06558422?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2027-01-01. Estimated completion is 2029-02-28.
What interventions are being tested in trial NCT06558422?
The interventions under investigation include: Glucagon (DRUG), Octreotide Acetate (DRUG), Insulin human (DRUG), Growth Hormone, Human (DRUG), 20% D-glucose (aq) (DRUG).
Who is sponsoring clinical trial NCT06558422?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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