Overview

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.