Human Models of Selective Insulin Resistance: Pancreatic Clamp (NCT06558422)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Columbia University Irving Medical Center — New York, New York
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
- Insulin human (DRUG)
- Octreotide Acetate (DRUG)
- Glucagon (DRUG)
- Growth Hormone, Human (DRUG)
- 20% D-glucose (aq) (DRUG)
- 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)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Columbia University Irving Medical Center — New York, New York
📞 Contact the Study Coordinator
Phone: (212) 305-6289
Email: jrc2175@cumc.columbia.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.