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Clinical Trial Details

Trial ID: L2212
Source ID: NCT06558422
Associated Drug: Insulin Human
Title: Human Models of Selective Insulin Resistance: Pancreatic Clamp
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Insulin Resistance|Hyperinsulinemia|Metabolic Dysfunction Associated Steatotic Liver Disease|Non-Alcoholic Fatty Liver Disease|Prediabetic State|Obesity
Interventions: DRUG: Insulin human|DRUG: Octreotide Acetate|DRUG: Glucagon|DRUG: Growth Hormone, Human|DRUG: 20% D-glucose (aq)|DIAGNOSTIC_TEST: [6,6-2H2] D-glucose|DIAGNOSTIC_TEST: [1-13C1] sodium acetate|DIETARY_SUPPLEMENT: Nestle BOOST Plus|DIETARY_SUPPLEMENT: KIND Bar|DEVICE: Harvard Apparatus PHD ULTRA CP syringe pump|DEVICE: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
Outcome Measures: Primary: Hepatic de novo lipogenesis (DNL) (absolute value), Percent incorporation of newly synthesized fatty acids into plasma or very low-density lipoprotein (VLDL) triglyceride (TG) during pancreatic clamp procedures. (Unit: %), Up to 6.5 hours of pancreatic clamp protocol|Hepatic de novo lipogenesis (DNL) (relative value), Percent incorporation of newly synthesized fatty acids into plasma or VLDL TG during pancreatic clamp procedures. (Unit: fold difference and/or ∆% versus other group), Up to 6.5 hours of pancreatic clamp protocol|Endogenous glucose production (EGP) (absolute value), Calculated from D2G tracer enrichment by the Steele equations during pancreatic clamp procedures. (Units: mg/kg/min), Up to 6.5 hours of pancreatic clamp protocol|Endogenous glucose production (EGP) (relative value), Calculated from D2G tracer enrichment by the Steele equations during pancreatic clamp procedures. (Units: fold difference and/or ∆% versus other group), Up to 6.5 hours of pancreatic clamp protocol|Plasma glucose level, Plasma glucose level during pancreatic clamp procedures. (Units: mg/dL), Up to 6.5 hours of pancreatic clamp protocol|Serum insulin level, Serum insulin level during pancreatic clamp procedures (Units: µU/mL), Up to 6.5 hours of pancreatic clamp protocol | Secondary: Serum or plasma triglyceride level, Serum or plasma triglyceride level in response to pancreatic clamp procedures (Units: mg/dL), Up to 6.5 hours of pancreatic clamp protocol|Plasma free fatty acids level, Plasma free fatty acids level in response to pancreatic clamp procedures. (Units: mmol/L), Up to 6.5 hours of pancreatic clamp protocol|Glucose kinetics: rate of appearance (absolute value), Calculated from D2G tracer enrichment by the Steele equations during pancreatic clamp procedures. (Units: mg/kg/min), Up to 6.5 hours of pancreatic clamp protocol|Glucose kinetics: rate of appearance (relative value), Calculated from D2G tracer enrichment by the Steele equations during pancreatic clamp procedures. (Units: fold difference and/or ∆% versus other group), Up to 6.5 hours of pancreatic clamp protocol|Glucose kinetics: rate of disappearance (absolute value), Calculated from D2G tracer enrichment by the Steele equations during pancreatic clamp procedures. (Units: mg/kg/min), Up to 6.5 hours of pancreatic clamp protocol|Glucose kinetics: rate of disappearance (relative value), Calculated from D2G tracer enrichment by the Steele equations during pancreatic clamp procedures. (Units: fold difference and/or ∆% versus other group), Up to 6.5 hours of pancreatic clamp protocol | Other: Serum C-peptide level, Serum C-peptide level in response to octreotide infusion during pancreatic clamps. (Units: ng/mL), Up to 6.5 hours of pancreatic clamp protocol|Plasma glucagon level, Plasma glucagon level in response to octreotide infusion during pancreatic clamps. (Units: ng/L), Up to 6.5 hours of pancreatic clamp protocol|Serum growth hormone level, Serum growth hormone level in response to octreotide infusion during pancreatic clamps. (Units: ng/mL), Up to 6.5 hours of pancreatic clamp protocol
Sponsor/Collaborators: Sponsor: Columbia University | Collaborators: University of California, Berkeley|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2025-06-01
Completion Date: 2028-02-28
Results First Posted:
Last Update Posted: 2025-01-08
Locations: Columbia University Irving Medical Center, New York, New York, 10032, United States
URL: https://clinicaltrials.gov/show/NCT06558422