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Gastric Bypass Surgery for Type 2 Diabetes
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
Healthy non-surgical patients with no personal history of diabetes
Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl
Must not have
Myasthenia gravis
Development of any serious medical or psychiatric illness during recruitment or studies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial is studying how well gastric bypass surgery works in treating patients with type 2 diabetes.
Who is the study for?
This trial is for individuals who've had gastric bypass surgery and either have low blood sugar episodes or are symptom-free. It's also open to healthy people without diabetes. Participants must be able to visit Cedars-Sinai Medical Center but can't join if they have certain conditions like an enlarged prostate, glaucoma, serious organ diseases, uncontrolled hypertension or cholesterol, significant anemia, or are pregnant.
What is being tested?
The study investigates how factors like hormones and nerves affect insulin release after gastric bypass surgery. It involves giving participants drugs such as Exendin-(9-39), Atropine, GLP-1, and GIP to see their effect on insulin secretion in those with and without post-surgery hypoglycemia compared to non-operated controls.
What are the potential side effects?
Potential side effects from the drugs used in this trial may include digestive disturbances due to altered gut hormone activity and dry mouth or vision problems from atropine. The exact side effects will depend on individual responses to the medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy, have never had surgery, and do not have diabetes.
Select...
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:Select...
I have myasthenia gravis.
Select...
I have not developed a serious illness or psychiatric condition recently.
Select...
I have had gastric bypass surgery and am experiencing severe blockage or diarrhea.
Select...
I have an enlarged prostate.
Select...
I have type 2 diabetes.
Select...
I have a brain condition.
Select...
My blood pressure or cholesterol levels are not under control.
Select...
I am unable to understand and agree to the study's details on my own.
Select...
I have a history of glaucoma.
Select...
I am healthy, not planning surgery, and have diabetes.
Select...
I do not have active heart, lung, liver, GI, or kidney disease.
Select...
My blood pressure is over 140/90 and I have a history of high cholesterol.
Select...
I am not on any medication that interacts with atropine, or I can stop it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Trial Design
3Treatment groups
Experimental Treatment
Group I: atropineExperimental Treatment1 Intervention
To evaluate the effect of neural activation on insulin secretion and glucose metabolism
Group II: GLP-1 and GIPExperimental Treatment1 Intervention
to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
Group III: Exendin-(9-39)Experimental Treatment1 Intervention
To evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
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
476 Previous Clinical Trials
92,750 Total Patients Enrolled
Marzieh Salehi, MD, MSPrincipal InvestigatorMarzieh Salehi
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have low hemoglobin levels (less than 11g/dL).I am healthy, have never had surgery, and do not have diabetes.I have myasthenia gravis.I have not developed a serious illness or psychiatric condition recently.I have had gastric bypass surgery and am experiencing severe blockage or diarrhea.I can travel to Cedars-Sinai Medical Center for the study.I have an enlarged prostate.I have type 2 diabetes.I have a brain condition.I have had low blood sugar levels below 50 mg/dl after gastric bypass surgery.My blood pressure or cholesterol levels are not under control.I am unable to understand and agree to the study's details on my own.I have had weight loss surgery and feel no symptoms.I have a history of glaucoma.I am healthy, not planning surgery, and have diabetes.I do not have active heart, lung, liver, GI, or kidney disease.My blood pressure is over 140/90 and I have a history of high cholesterol.I am not on any medication that interacts with atropine, or I can stop it.
Research Study Groups:
This trial has the following groups:- Group 1: Exendin-(9-39)
- Group 2: atropine
- Group 3: GLP-1 and GIP
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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.