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Hormone Therapy

Insulin Pulses for Prediabetes

N/A
Waitlist Available
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
Be older than 18 years old
Must not have
Symptomatic macrovascular or microvascular disease
Use of any glucose-lowering agents including metformin or sulfonylureas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximate entropy (apen) will be calculated from the insulin concentrations observed every 2 minutes between -45 and 0 minutes
Awards & highlights

Summary

This trial aims to understand how the body regulates blood sugar levels when a person hasn't eaten (fasting state) in comparison to after a meal (postprandial state). The study will focus

Who is the study for?
This trial is for individuals with prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. Participants should have fasting hyperglycemia and be interested in how their body regulates glucose when they haven't eaten.
What is being tested?
The study is looking at the effects of insulin and insulin pulses on blood sugar levels during fasting. It involves administering saline (saltwater solution), intralipid (a fat emulsion), and heparin (a medication that prevents blood clots) to see how these affect glucose control.
What are the potential side effects?
Potential side effects may include discomfort at the injection site from saline, changes in blood lipid levels due to intralipid, and increased bleeding risk or bruising from heparin.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have symptoms from large or small vessel blood disease.
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I am taking medication to lower my blood sugar.
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I am not pregnant at the time of joining the study.
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I have another active illness or cancer.
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I have had surgery in my upper stomach area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximate entropy (apen) will be calculated from the insulin concentrations observed every 2 minutes between -45 and 0 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximate entropy (apen) will be calculated from the insulin concentrations observed every 2 minutes between -45 and 0 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insulin pulse orderliness
Suppression of Endogenous glucose production (EGP) by insulin

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intralipid and heparinActive Control1 Intervention
Between 0600 (-180 min) and 1300 (240 min) Intralipid (20%, 0.011ml/kg/min; Baxter, Healthcare, Deerfield, IL) and heparin (200 units prime, 0.2 unit/kg/min continuous) will be infused to induce acute insulin resistance.
Group II: SalinePlacebo Group1 Intervention
Between 0600 (-180 min) and 1300 (240 min) saline will be infused

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,385 Total Patients Enrolled
Adrian Vella, MDPrincipal InvestigatorMayo Clinic
16 Previous Clinical Trials
569 Total Patients Enrolled
~40 spots leftby Sep 2026
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