Human Models of Selective Insulin Resistance: Pancreatic Clamp
Public ClinicalTrials.gov record NCT06558422. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06558422
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Interventions
- Insulin human Drug
- Octreotide Acetate Drug
- Glucagon Drug
- Growth Hormone, Human Drug
- 20% D-glucose (aq) Drug
- [6,6-2H2] D-glucose Diagnostic Test
- [1-13C1] sodium acetate Diagnostic Test
- Nestle BOOST Plus Dietary Supplement
- KIND Bar Dietary Supplement
- Harvard Apparatus PHD ULTRA CP syringe pump Device
- Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer Device
Drug · Diagnostic Test · Dietary Supplement + 1 more
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2026
- Primary completion
- Dec 30, 2028
- Completion
- Feb 27, 2029
- Last update posted
- Feb 5, 2026
2027 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06558422, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 5, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06558422 live on ClinicalTrials.gov.