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Gastric Bypass and Sleeve Gastrectomy for Hypoglycemia

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

Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center

Asymptomatic individuals with bariatric surgery

Must not have

Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study

History of glaucoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial will study how well two types of weight-loss surgery, gastric bypass and sleeve gastrectomy, improve glucose metabolism by looking at neural and hormonal factors.

Who is the study for?

This trial is for individuals who've had bariatric surgery and are asymptomatic, can visit Cedars-Sinai Medical Center, and don't have a personal history of diabetes. It's not for those with enlarged prostates, pregnant women, anyone unable to consent, diabetics, or people with certain medical conditions like uncontrolled hypertension or serious organ diseases.

What is being tested?

The study investigates how gastric bypass and sleeve gastrectomy affect blood sugar control after eating by looking at neural and hormonal responses. Participants will be given Exendin-(9-39) or Atropine to see the effects on glucose metabolism.

What are the potential side effects?

Potential side effects from Exendin-(9-39) and Atropine may include dry mouth, blurred vision, constipation, urinary retention in men due to an enlarged prostate (for Atropine), increased heart rate, 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 can travel to Cedars-Sinai Medical Center for the study.

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I have had weight loss surgery and feel no symptoms.

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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 am not on medications that interact with atropine or can stop them if needed.

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I have a history of glaucoma.

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I am unable to understand and agree to the study's procedures and risks.

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I have myasthenia gravis.

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I have an enlarged prostate.

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I have uncontrolled high blood pressure or cholesterol.

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I have type 2 diabetes.

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

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I have high blood pressure over 140/90 and problems with my cholesterol.

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I have a brain condition.

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I have an active heart, lung, liver, GI, or kidney disease.

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

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

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.

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: Exendin-(9-39)Experimental Treatment1 Intervention

To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

Group II: AtropineExperimental Treatment1 Intervention

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

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 / 16Eligibility 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

92,775 Total Patients Enrolled

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

2,448 Previous Clinical Trials

4,332,204 Total Patients Enrolled

Marzieh Salehi, MD, MSPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio

1 Previous Clinical Trials

160 Total Patients Enrolled

Media Library

Gastric Bypass Surgery (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02823665 — Phase < 1

Gastric Bypass Research Study Groups: Exendin-(9-39), Atropine

Gastric Bypass Clinical Trial 2023: Gastric Bypass Surgery Highlights & Side Effects. Trial Name: NCT02823665 — Phase < 1

Gastric Bypass Surgery (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02823665 — Phase < 1

Gastric Bypass Patient Testimony for trial: Trial Name: NCT02823665 — Phase < 1

~13 spots leftby Aug 2025

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