The Effects of Bariatric Surgeries on Glucose Metabolism

NCT ID: NCT02823665

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2027-08-31

Brief Summary

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The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.

Detailed Description

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The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures.

Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.

Conditions

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Post Bariatric Surgery Gastric Bypass Sleeve Gastrectomy Hypoglycemia After Gastric Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Exendin-(9-39)

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

Group Type EXPERIMENTAL

Exendin-(9-39)

Intervention Type DRUG

A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

Atropine

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

Group Type EXPERIMENTAL

Atropine

Intervention Type DRUG

A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.

Interventions

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Exendin-(9-39)

A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

Intervention Type DRUG

Atropine

A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.

Intervention Type DRUG

Other Intervention Names

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no other name for Exendin-(9-39) Atropine sulfate

Eligibility Criteria

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Inclusion Criteria

* Hypoglycemic RYGB patients with documented blood glucose level \<50 mg/dl
* Asymptomatic individuals with bariatric surgery
* Healthy non-surgical patients with no personal history of diabetes
* Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center

Exclusion Criteria

* Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin \<11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies;
* RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea.
* Healthy non-surgical patients with personal history of diabetes

For administration of atropine, the following exclusions also apply:

* History of glaucoma
* Uncontrolled hypertension (any subjects with BP\>140/90 and history of dyslipidemia
* Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)
* Myasthenia gravis
* Brain pathology
* Enlarged prostate in men
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marzieh Salehi, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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Texas Diabetes Institute - University Health System

San Antonio, Texas, United States

Site Status RECRUITING

South Texas Veterans Health Care System

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marzieh Salehi, MD MS

Role: CONTACT

210-567-6691

Jennifer Foster, MSN

Role: CONTACT

210-450-8696

Facility Contacts

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Marzieh Salehi, MD

Role: primary

210-567-6691

Jennifer Foster, MSN

Role: backup

210-450-8696

Marzieh Salehi, MD

Role: primary

210-567-6691

Jennifer Foster, MSN

Role: backup

210-450-8696

Other Identifiers

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1R01DK105379-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20180070H

Identifier Type: -

Identifier Source: org_study_id

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