Status:
RECRUITING
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy
Type 2 Diabetes
Eligibility:
All Genders
25-65 years
Phase:
PHASE4
Brief 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.
Detailed Description
T2DM and prediabetes are characterized by abnormal post-prandial suppression of glucagon, which contributes to postprandial hyperglycemia by increasing endogenous glucose production (EGP). In rodents,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05264727
Start Date
May 30 2023
End Date
December 31 2025
Last Update
June 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905