Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Columbia University.
NCT06558422 is a Phase 1 study that has not yet begun recruiting, run by Columbia University. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent incorporation of newly synthesized fatty acids into plasma or very low-density lipoprotein (VLDL) triglyceride (TG) during pancreatic clamp procedures. (Unit: %)
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 |
What is known before NCT06558422 opens enrollment
NCT06558422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 5 interventions - of which Glucagon is the first listed.
NCT06558422 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06558422's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI