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Exendin-(9-39) for Post-Bariatric Surgery Glucose Metabolism (GLP-1 Trial)

Phase < 1

Recruiting

Led By Marzieh Salehi, MD,MS

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

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

Must have

healthy control without diabetes or active organ disease

age 18-65

Must not have

GI obstruction

significant anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well gastric bypass surgery works in improving glucose metabolism by looking at the mechanisms by which it does so.

Who is the study for?

This trial is for adults aged 18-65 who have had gastric bypass surgery and are experiencing recurrent low blood sugar. Healthy individuals without diabetes or active organ disease can also participate. People with significant anemia, current diabetes (unless awaiting bariatric surgery), pregnancy, or GI obstruction cannot join.

What is being tested?

The study aims to understand how gastric bypass improves blood sugar control by focusing on incretin hormones that affect insulin secretion. Participants will undergo tests like the intravenous-oral hyperglycemic clamp to investigate these effects.

What are the potential side effects?

Potential side effects from the interventions (exendin-(9-39)) may include reactions at the injection site, changes in blood sugar levels, nausea, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I do not have diabetes or any active organ disease.

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I am between 18 and 65 years old.

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I have had weight loss surgery.

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I have had low blood sugar episodes after gastric bypass surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blockage in my digestive tract.

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I have severe anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: hyperglycemic clamp-Meal tolerance testExperimental Treatment1 Intervention

these studies are to evaluate the effect of exendin-9 on insulin secretion before and after meal ingestion in patients after bariatric surgeries compared to non-surgical controls

Group II: Labeled meal tolerance testExperimental Treatment1 Intervention

The effect of GLP-1 receptor blockade on glucose tolerance and glucose kinetics are evaluated in the group patients with bariatric surgery vs. nonsurgical using exendin-9-39 infusion during one of the the 2-day dual tracer studies of meal tolerance test

0 / 6Eligibility criteria met