| Trial ID: | L6500 |
| Source ID: | NCT06592261
|
| Associated Drug: |
Insulin Regular, 2.0-3.2 Mu/M2/Min (Euinsulinemia)
|
| Title: |
Graded Insulin Suppression Test P&F
|
| Acronym: |
GIST
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Insulin Resistance|Hyperinsulinemia|Obesity|Healthy
|
| Interventions: |
DRUG: Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia)|DRUG: Insulin regular, 32 mU/m2/min (hyperinsulinemia)|DRUG: Octreotide Acetate, 6-45 ng/kg/min|DRUG: Dextrose 20 % in Water|DRUG: Glucagon, 0-0.5 ng/kg/min
|
| Outcome Measures: |
Primary: Steady-state plasma glucose at euinsulinemia (E-SSG), Plasma glucose level at steady state while insulin infusion rate is 4 mU/m2/min (units: mg/dL), 150-180 minutes during GIST protocol|Steady-state plasma glucose at hyperinsulinemia (H-SSG), Plasma glucose level at steady state while insulin infusion rate is 32 mU/m2/min and glucose infusion rate is 267 mg/m2/min, reflective of insulin sensitivity (units: mg/dL), 270-300 minutes during GIST protocol | Secondary: Steady-state plasma free fatty acids (FFA) at euinsulinemia, Plasma FFA level while insulin infusion rate is 4 mU/m2/min (units: mmol/L), 150-180 minutes during GIST protocol|Steady-state plasma free fatty acids (FFA) at hyperinsulinemia, Plasma FFA level while insulin infusion rate is 32 mU/m2/min (units: mmol/L), 270-300 minutes during GIST protocol | Other: Steady-state serum insulin at euinsulinemia (E-SSI), Serum insulin level at steady state while insulin infusion rate is 4 mU/m2/min (units: mU/L), 150-180 minutes during GIST protocol|Steady-state serum insulin at hyperinsulinemia (H-SSI), Serum insulin level at steady state while insulin infusion rate is 32 mU/m2/min and glucose infusion rate is 267 mg/m2/min (units: mU/L), 270-300 minutes during GIST protocol|Steady-state plasma glucagon level at euinsulinemia, Plasma glucagon level while insulin infusion rate is 4 mU/m2/min (units: ng/L), 150-180 minutes during GIST protocol|Steady-state plasma glucagon level at hyperinsulinemia, Plasma glucagon level while insulin infusion rate is 32 mU/m2/min (units: ng/L), 270-300 minutes during GIST protocol|Steady-state serum growth hormone (GH) level at euinsulinemia, Serum GH level while insulin infusion rate is 4 mU/m2/min (units: ng/mL), 150-180 minutes during GIST protocol|Steady-state serum growth hormone (GH) level at hyperinsulinemia, Serum GH level while insulin infusion rate is 32 mU/m2/min (units: ng/mL), 270-300 minutes during GIST protocol
|
| Sponsor/Collaborators: |
Sponsor: Columbia University | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|University of Pisa
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2024-09-16
|
| Completion Date: |
2025-08
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-16
|
| Locations: |
Columbia University Irving Medical Center, New York, New York, 10032, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06592261
|
