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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin levels measured after nutrient ingestion

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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,214 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,866 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

Frequently Asked Questions

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

What medical maladies is Atropine employed to address?

"Atropine is a medication that can be employed to treat an array of conditions, including uncontrollable laughter, rhinorrhoea, and abnormal dilation of the pupils. Additionally, it can also aid in the secretion of bile fluid."

Answered by AI

Are there any other scientific investigations involving Atropine?

"Currently, 22 Atropine clinical trials are in progress and 6 of them have reached Phase 3. Most of the studies are located in Shanghai, but there is a total of 149 sites administering this medication across the globe."

Answered by AI

Are applications currently being accepted for this research initiative?

"Affirmative. According to the clinicaltrials.gov webpage, this trial that was first announced on July 1st 2015 is recruiting participants. 200 individuals are needed from 2 hospitals for enrolment in the study."

Answered by AI

Does your study accept participants who are 25 years of age or older?

"This clinical trial states that the lowest age for participation is 18 and the highest permissible age for enrollment is 65."

Answered by AI

Approximately how many participants are enrolled in this research endeavor?

"Affirmative. Evidenced from the clinicaltrials.gov website, this medical investigation is currently in search of participants; first posted on July 1st 2015 and most recently updated November 1st 2022. The trial requires 200 individuals to participate at 2 separate sites."

Answered by AI

Who is eligible to enroll in this research project?

"This medical trial seeks 200 participants between the ages of 18 and 65 who currently have bypass, gastric. In addition to this criteria, these patients must display evidence of hypoglycemia (blood glucose <50 mg/dl), be able to physically come to Cedars-Sinai Medical Centre for treatment, show no symptoms associated with bariatric surgery or diabetes, and not have a personal history of diabetes."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Pennsylvania
What site did they apply to?
South Texas Veterans Health Care System
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I'm sorry I thought this was in Scranton PA.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Effects of Bariatric Surgeries on Glucose Metabolism
2015. "The Effects of Bariatric Surgeries on Glucose Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02823665.
All > Hypoglycemia > Gastric Bypass
~25 spots leftby Aug 2025
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