Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.