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

Overview

About this study

The purpose of this study is to determine how amino acids alter the suppression of α-cell secretion by glucose.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Obese Subjects with Type 2 Diabetes:

  • Age ≥ 25 or ≤ 65 years.
  • 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:

  • Age ≤ 25 or ≥ 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
  • HbA1c ≥ 8.5%.
  • BMI ≤ 28 Kg/M^2.
  • 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/M^2.
  • > 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique.

Exclusion Criteria - Obese Subjects without Type 2 Diabetes:

  • Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
  • HbA1c ≥ 6.5%.
  • BMI ≤ 28 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.

Inclusion Criteria - Lean Subjects without Diabetes:

  • Age ≥ 25 or ≤ 65 years (match subjects with T2DM).
  • BMI ≤ 25 Kg/M^2). 

Exclusion Criteria - Lean Subjects without Diabetes:

  • Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
  • 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.

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adrian Vella, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Paula Giesler R.N.

(507) 255-9278

Giesler.Paula@mayo.edu

More information

Publications

Publications are currently not available