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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each study of 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 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each study of 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 of 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
Gut hormones and neural signaling contribution to insulin secretion rate and glucose tolerance
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
453 Previous Clinical Trials
91,270 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research allow geriatric participants?
"This clinical trial requires that participants are within the 18 to 65 age range. For those outside of this demographic, there are 24 studies for minors and 68 trials specifically geared towards elderly patients."
Answered by AI
To what ailment are GLP-1 and GIP most often prescribed?
"GLP-1 and GIP are clinically used to reduce cases of uncontrolled lauging, as well as ailments such as rhinorrhoea, pupil constriction, and secretion of bile."
Answered by AI
Am I eligible to enroll in this clinical trial?
"To be eligible to partake in this clinical trial, potential participants must have hypoglycemia and fall within the 18-65 age bracket. Additionally, they should be asymptomatic bariatric surgery patients or healthy individuals with no history of diabetes; Lastly, they must also possess enough mobility to come our research centre at Cedars-Sinai Medical Center."
Answered by AI
How many volunteers are participating in this clinical experiment?
"Affirmative. Data hosted on clinicaltrials.gov suggests that this medical experiment, initially posted October 1st 2009, is actively searching for participants. 160 individuals need to be enrolled across 2 sites."
Answered by AI
What past experiments have utilized GLP-1 and GIP in the study of treatments?
"Currently, 22 clinical trials are investigating GLP-1 and GIP with 6 of these studies in the final Phase 3. Shanghai is hosting some of them but there are 149 global locations engaged in this research effort."
Answered by AI
Is there currently an open enrollment period for this trial?
"Clinicaltrials.gov affirms that this medical experiment, initially launched on October 1st 2009, is presently recruiting for participants. The trial details were last revised August 5th 2022."
Answered by AI
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