NCT02823665

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
15mo left

Started Jul 2015

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2015Aug 2027

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

11.1 years

First QC Date

October 22, 2015

Last Update Submit

September 8, 2025

Conditions

Post Bariatric SurgeryGastric BypassSleeve GastrectomyHypoglycemia After Gastric Bypass

Keywords

gastric bypass surgeryHypoglycemiasleeve gastrectomyglucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Insulin levels measured after nutrient ingestion

    Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.

Study Arms (2)

Exendin-(9-39)

EXPERIMENTAL

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

Drug: Exendin-(9-39)

Atropine

EXPERIMENTAL

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

Drug: Atropine

Interventions

Exendin-(9-39)DRUG

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

Also known as: no other name for Exendin-(9-39)
Exendin-(9-39)
AtropineDRUG

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

Also known as: Atropine sulfate
Atropine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Diabetes Institute - University Health System

San Antonio, Texas, 78207, United States

RECRUITING

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Interventions

exendin (9-39)Atropine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Marzieh Salehi, MD, MS

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marzieh Salehi, MD MS

CONTACT

210-567-6691salehi@uthscsa.edu

Jennifer Foster, MSN

CONTACT

210-450-8696fosterj6@uthscsa.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

July 6, 2016

Study Start

July 1, 2015

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)