Human Models of Selective Insulin Resistance: Pancreatic Clamp
Status:
NOT_YET_RECRUITING
Trial end date:
2028-02-28
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
Columbia University
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of California, Berkeley
Treatments:
Glucagon Glucose Human Growth Hormone Insulin Octreotide