Clinical trial
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT05264727
Active, not recruitingPhase 4Interventional
What this study is about
This study is being done to better understand how amino acids alter the release of glucagon and insulin compared to glucose alone in health and disease.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age25 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionHealthy, Type 2 Diabetes, Obesity
Full registry criteria
Inclusion Criteria - Obese Subjects with Type 2 Diabetes: * HbA1c ≤ 8.5% (type 2 diabetic subjects). * HbA1c ≤ 6.5% (obese and lean subjects). * BMI ≥ 28 Kg/M\^2 (Obese subjects with and without type 2 diabetes). * BMI ≤ 25 Kg/M\^2 (Lean subjects without type 2 diabetes). * Use of sulfonylureas or metformin only (type 2 diabetec subjects). * For female subjects: negative pregnancy test at the time of enrollment or study. * No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * No active systemic illness or malignancy. * No symptomatic macrovascular or microvascular disease. * No contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \> 35%. * TSH \> 0.4 or \< 5.5. * Consumption of \< 2 alcohol drinks per day or \< 14 per week or a negative AUDIT questionnaire. Exclusion Criteria - Obese Subjects with Type 2 Diabetes: * HbA1c ³ 8.5% * BMI ≤ 28 Kg/M2 * Use of insulin or agents other than sulfonylureas or metformin. * For female subjects: positive pregnancy test at the time of enrollment or study * History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \< 35% * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire. Inclusion Criteria - Obese Subjects without Type 2 Diabetes: * BMI ≥ 28 Kg/M2. * \> 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique. Exclusion Criteria - Obese Subjects without Type 2 Diabetes: * HbA1c ≥ 6.5% * BMI ≤ 28 Kg/M2 * Use of any glucose-lowering agents including metformin or sulfonylureas. * For female subjects: positive pregnancy test at the time of enrollment or study * History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \< 35% * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire. Inclusion Criteria - Lean subjects without Diabetes: \- BMI ≤ 25 Kg/M\^2). Exclusion Criteria - Lean Subjects without Diabetes: * HbA1c ≥ 6.5%. * BMI ≥ 25 Kg/M\^2. * Use of any glucose-lowering agents including metformin or sulfonylureas. * For female subjects: positive pregnancy test at the time of enrollment or study. * History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \< 35%. * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire. * Liver fat content ≥ 5% as determined by MRI using the proton density fat fraction (PDFF) technique.
Treatments and study arms
Dextrose
Drug
Intravenous graded glucose infusion using 50% dextrose will commence at 1mg/kg/min and increase to 2 (0900), 4 (1000) and 8mg/kg/min (1100) every 60 minutes
Clinisol 15%
Drug
Intravenous infusion 0.003ml/kg/min infused from 0 to 240 minutes
Primary outcomes
Change in Glucagon Suppression (G50) caused by amino acids vs. saline240 minutes of study
concentration of glucose necessary to suppress glucagon by 50%
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Mayo Clinic Rochester🇺🇸 Rochester, Minnesota, United States