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Gastric Bypass Surgery for Type 2 Diabetes

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 non-surgical patients with no personal history of diabetes

Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl

Must not have

Myasthenia gravis

Development of any serious medical or psychiatric illness during recruitment or studies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is studying how well gastric bypass surgery works in treating patients with type 2 diabetes.

Who is the study for?

This trial is for individuals who've had gastric bypass surgery and either have low blood sugar episodes or are symptom-free. It's also open to healthy people without diabetes. Participants must be able to visit Cedars-Sinai Medical Center but can't join if they have certain conditions like an enlarged prostate, glaucoma, serious organ diseases, uncontrolled hypertension or cholesterol, significant anemia, or are pregnant.

What is being tested?

The study investigates how factors like hormones and nerves affect insulin release after gastric bypass surgery. It involves giving participants drugs such as Exendin-(9-39), Atropine, GLP-1, and GIP to see their effect on insulin secretion in those with and without post-surgery hypoglycemia compared to non-operated controls.

What are the potential side effects?

Potential side effects from the drugs used in this trial may include digestive disturbances due to altered gut hormone activity and dry mouth or vision problems from atropine. The exact side effects will depend on individual responses to the medications.

Eligibility Criteria

Inclusion Criteria

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

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I am healthy, have never had surgery, and do not have diabetes.

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I have had low blood sugar levels below 50 mg/dl 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 myasthenia gravis.

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I have not developed a serious illness or psychiatric condition recently.

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I have had gastric bypass surgery and am experiencing severe blockage or diarrhea.

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I have an enlarged prostate.

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I have type 2 diabetes.

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I have a brain condition.

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My blood pressure or cholesterol levels are not under control.

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I am unable to understand and agree to the study's details on my own.

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I have a history of glaucoma.

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I am healthy, not planning surgery, and have diabetes.

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I do not have active heart, lung, liver, GI, or kidney disease.

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My blood pressure is over 140/90 and I have a history of high cholesterol.

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I am not on any medication that interacts with atropine, or I can stop it.

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3Treatment groups

Experimental Treatment

Group I: atropineExperimental Treatment1 Intervention

To evaluate the effect of neural activation on insulin secretion and glucose metabolism

Group II: GLP-1 and GIPExperimental Treatment1 Intervention

to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones

Group III: Exendin-(9-39)Experimental Treatment1 Intervention

To evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exendin-(9-39)

2009

Completed Phase 2

~40

Atropine

FDA approved

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

476 Previous Clinical Trials

92,815 Total Patients Enrolled

1 Trials studying Hypoglycemia

200 Patients Enrolled for Hypoglycemia

Marzieh Salehi, MD, MSPrincipal InvestigatorMarzieh Salehi

1 Previous Clinical Trials

200 Total Patients Enrolled

1 Trials studying Hypoglycemia

200 Patients Enrolled for Hypoglycemia

Media Library

GLP-1 and GIP Clinical Trial Eligibility Overview. Trial Name: NCT00992901 — Phase < 1

Hypoglycemia Research Study Groups: Exendin-(9-39), atropine, GLP-1 and GIP

Hypoglycemia Clinical Trial 2023: GLP-1 and GIP Highlights & Side Effects. Trial Name: NCT00992901 — Phase < 1

GLP-1 and GIP 2023 Treatment Timeline for Medical Study. Trial Name: NCT00992901 — Phase < 1

~7 spots leftby Aug 2025

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