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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 belowSelect...
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 weeks3 visits
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.
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.
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
457 Previous Clinical Trials
91,262 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,379 Previous Clinical Trials
4,315,319 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can travel to Cedars-Sinai Medical Center for the study.I am not on medications that interact with atropine or can stop them if needed.I have a history of glaucoma.I am unable to understand and agree to the study's procedures and risks.I have myasthenia gravis.I have an enlarged prostate.I have had weight loss surgery and feel no symptoms.You have low levels of hemoglobin in your blood.I have uncontrolled high blood pressure or cholesterol.I have type 2 diabetes.I am healthy, have never had surgery, and do not have diabetes.I am healthy, not planning surgery, and have diabetes.I have high blood pressure over 140/90 and problems with my cholesterol.I have a brain condition.I have an active heart, lung, liver, GI, or kidney disease.I have had low blood sugar levels below 50 mg/dl after gastric bypass surgery.I have had gastric bypass surgery and am experiencing severe blockage or diarrhea.
Research Study Groups:
This trial has the following groups:- Group 1: Exendin-(9-39)
- Group 2: Atropine
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Gastric Bypass Patient Testimony for trial: Trial Name: NCT02823665 — Phase < 1
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