Overview

Dexamethasone/Pancreatic Clamp P&F

Status:
Not yet recruiting
Trial end date:
2026-03-31
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 in the setting of dexamethasone-induced insulin resistance. The investigators will recruit participants with a history of overweight/obesity but no history of prediabetes or diabetes. Participants will be rendered temporarily insulin resistant by taking seven doses of dexamethasone. They will then 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
Collaborators:
Albert Einstein College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Glucagon
Glucagon-Like Peptide 1
Hormones
Insulin
Insulin, Globin Zinc
Octreotide