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

Q: How many individuals have signed up to be a part of this clinical trial?

Affirmative. The information available on clinicaltrials.gov confirms that this study, which was initially listed as of November 1st 2005, is actively recruiting patients and aims to enroll 80 people from two medical centres.

Q: Are geriatric individuals being considered for enrollment in the experiment?

This study is only open to individuals aged 18 and over, but younger than 65.

Q: Are there opportunities currently available to participate in this experiment?

Verified by clinicaltrials.gov, this study is now open for patient recruitment; it was initiated in November 2005 and updated last August 2022.

Q: What qualifications must potential participants have to join this experiment?

For this trial, 80 individuals aged 18-65 who have recently undergone bariatric surgery are required. Additionally, they ought to not possess any active organ disease or <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> and must additionally demonstrate recurrent hypoglycemia post <a href="https://www.withpower.com/clinical-trials/gastric-bypass">gastric bypass</a>.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year (10 sessions)

Awards & highlights

GLP-1 Trial 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.Check my eligibility

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.See study design

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.

GLP-1 Trial 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.

GLP-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year (10 sessions)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year (10 sessions)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year (10 sessions) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated

GLP-1 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,350 Total Patients Enrolled

Marzieh Salehi, MD,MSPrincipal InvestigatorMarzieh Salehi

Media Library

exendin-(9-39) Clinical Trial Eligibility Overview. Trial Name: NCT01803451 — Phase < 1

Post-Bariatric Surgery Research Study Groups: hyperglycemic clamp-Meal tolerance test, Labeled meal tolerance test

Post-Bariatric Surgery Clinical Trial 2023: exendin-(9-39) Highlights & Side Effects. Trial Name: NCT01803451 — Phase < 1

exendin-(9-39) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01803451 — Phase < 1

Frequently Asked Questions

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

How many individuals have signed up to be a part of this clinical trial?

"Affirmative. The information available on clinicaltrials.gov confirms that this study, which was initially listed as of November 1st 2005, is actively recruiting patients and aims to enroll 80 people from two medical centres."

Answered by AI

Are geriatric individuals being considered for enrollment in the experiment?

"This study is only open to individuals aged 18 and over, but younger than 65."

Answered by AI

Are there opportunities currently available to participate in this experiment?

"Verified by clinicaltrials.gov, this study is now open for patient recruitment; it was initiated in November 2005 and updated last August 2022."

Answered by AI

What qualifications must potential participants have to join this experiment?

"For this trial, 80 individuals aged 18-65 who have recently undergone bariatric surgery are required. Additionally, they ought to not possess any active organ disease or diabetes and must additionally demonstrate recurrent hypoglycemia post gastric bypass."

Answered by AI