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

NCT05264727 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: 22-000306R01DK116231
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Glucagon Suppression (G50) caused by amino acids vs. saline

  concentration of glucose necessary to suppress glucagon by 50%

  240 minutes of study

Secondary Outcomes (2)

• Glucagon suppression (G50) is greater in people with T2DM

  240 minutes of study

• glucagon suppression (G50) is greater in obese compared to lean people without T2DM

  240 minutes of study

Study Arms (2)

Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Saline and Glucose

EXPERIMENTAL

Study visit: Subjects will receive a caffeine free, standardized evening meal and remain fasting overnight. An IV infusion of saline and glucose (50%) will be given the next morning and continue until the end of study. Blood draws will be collected frequently from the IV line to monitor blood glucose levels.

Drug: Dextrose

Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Amino Acid and Glucose

EXPERIMENTAL

Study visit: Subjects will receive a caffeine free, standardized evening meal and remain fasting overnight. An IV infusion of glucose (50%) will be given the next morning together with an IV infusion of Clinisol 15% (an amino acid mixture) will be given the next morning and continue until the end of study. Blood draws will be collected frequently from the IV line to monitor blood glucose levels.

Drug: Dextrose; Drug: Clinisol 15%

Interventions

Clinisol 15% DRUG

Intravenous infusion 0.003ml/kg/min infused from 0 to 240 minutes

Also known as: Amino Acid Mixture

Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Amino Acid and Glucose

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

Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Amino Acid and Glucose; Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Saline and Glucose

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• BMI ≥ 28 Kg/M2.
• \> 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique.
• HbA1c ≥ 6.5%
• BMI ≤ 28 Kg/M2

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Glucose; Amino Acids

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Amino Acids, Peptides, and Proteins

Study Officials

• Adrian Vella, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: May 30, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)