🏛️ Verified NIH Record • Updated 2026-02-04

Human Models of Selective Insulin Resistance: Pancreatic Clamp (NCT06558422)

🟡 Not Yet Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Columbia University

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (74 items).

Location: Columbia University Irving Medical Center — New York, New York

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Unable to provide informed consent in English or Spanish
  • Unwillingness to use only bedpan or urinal to void or to refrain from non-emergent mobile device use during the clamp
  • Documented weight loss of ≥ 5% of baseline within the previous 3 months
  • Abnormal blood pressure (including on treatment, if prescribed)
  • Systolic blood pressure \< 90 mm Hg or \> 160 mm Hg, and/or
  • Diastolic blood pressure \< 60 mm Hg or \> 100 mm Hg
  • Abnormal resting heart rate: \< 60 or ≥ 110 bpm
  • Sinus brady- or tachycardia that has been worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion
  • Abnormal screening electrocardiogram (or if on file, performed within previous 90 days)
  • Laboratory evidence of diabetes mellitus:
  • Hemoglobin A1c ≥ 6.5%, and/or

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗