Overview

Pancreatic Clamp in NAFLD

Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and prediabetic state (i.e., prediabetes or impaired fasting glucose, with fasting hyperinsulinemia), with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.
Phase:
Phase 1
Details
Lead Sponsor:
Columbia University
Collaborator:
Albert Einstein College of Medicine
Treatments:
Glucagon
Hormones
Insulin
Insulin, Globin Zinc
Octreotide