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Glucose and Amino Acids for High Blood Sugar

Phase 4

Recruiting

Led By Adrian Vella, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Use of sulfonylureas or metformin only (type 2 diabetec subjects).

BMI ≥ 28 Kg/M^2 (Obese subjects with and without type 2 diabetes).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 240 minutes of study

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will help researchers understand how amino acids, compared to glucose, affect the release of insulin and glucagon in people with and without health conditions.

Who is the study for?

This trial is for people with high blood sugar, obesity, or type 2 diabetes. Diabetic participants need an HbA1c level below 8.5%, while obese and lean individuals must have it under 6.5%. Obese subjects should have a BMI of at least 28, and lean ones a BMI up to 25. Only diabetics on sulfonylureas or metformin can join, and women must not be pregnant. Those with major surgeries, active illnesses like cancer, severe vascular diseases, or who can't undergo MRI are excluded.

What is being tested?

The study tests how amino acids (using Clinisol) affect glucagon and insulin release compared to glucose alone (using Dextrose). It aims to understand these effects in healthy individuals as well as those with obesity or type 2 diabetes.

What are the potential side effects?

While the side effects aren't specified here, dextrose could cause high blood sugar levels if not monitored properly; Clinisol might lead to imbalances in electrolytes or fluid overload.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I only use sulfonylureas or metformin for my type 2 diabetes.

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My BMI is 28 or higher.

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I am not pregnant or have a negative pregnancy test.

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I have never had surgery on my upper stomach.

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I do not have any active illnesses or other types of cancer.

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I do not have symptoms from large or small blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 240 minutes of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~240 minutes of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 minutes of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Glucagon suppression (G50) is greater in people with T2DM

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Saline and GlucoseExperimental Treatment1 Intervention

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.

Group II: Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Amino Acid and GlucoseExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dextrose, unspecified form

FDA approved

0 / 6Eligibility criteria met