← Back to Search

Other

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

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

My BMI is 28 or higher.

Select...

I am not pregnant or have a negative pregnancy test.

Select...

I have never had surgery on my upper stomach.

Select...

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

Select...

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Glucagon suppression (G50) is greater in people with T2DM

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

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,215 Previous Clinical Trials

3,767,183 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,532 Total Patients Enrolled

Adrian Vella, MDPrincipal InvestigatorMayo Clinic

14 Previous Clinical Trials

449 Total Patients Enrolled

Media Library

Clinisol 15% (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05264727 — Phase 4

Type 2 Diabetes Research Study Groups: Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Saline and Glucose, Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Amino Acid and Glucose

Type 2 Diabetes Clinical Trial 2023: Clinisol 15% Highlights & Side Effects. Trial Name: NCT05264727 — Phase 4

Clinisol 15% (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05264727 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects could arise from using Clinisol 15%?

"There is already existing data confirming Clinisol 15%'s safety, so it was rated a 3."

Answered by AI

Who is eligible to enroll in this trial?

"Eligible candidates for this trial must have obesity and fall between the age range of 25 to 65. This medical research is seeking a total of 60 participants."

Answered by AI

Does this research study still have openings for participants?

"This research endeavour, which had its first posting on May 1st 2023 and was last modified a few months ago, is no longer recruiting participants. However, there are over two thousand other medical trials currently seeking volunteers."

Answered by AI

Is the age ceiling for this trial higher than 25 years?

"This clinical trial is exclusive to patients aged 25-65. However, there are 273 studies available for those under 18 and 1285 studies catering to individuals over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Adrian Vella 2023. "Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05264727.