- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05325736
Improvement in Glycemic Response After Bariatric Surgery
Study Overview
Status
Conditions
Detailed Description
Despite the vast knowledge linking the gut microbiome to metabolism and the glucose response, the relation still remains unclear. hopefully, a deep understanding of the mechanisms underlying metabolic improvement following bariatric surgery will make it possible to identify targets for pharmacological intervention, which will reduce the need for surgery and its risks.
Previous studies have characterized the microbiome after bariatric surgery, but most suffer from methodological limitations.
The current study has the potential to be innovative and make a significant contribution to understanding the mechanisms involved in early metabolic improvement after bariatric surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Avner Leshem, MD
- Phone Number: +972547487555
- Email: avner.leshem@weizmann.ac.il
Study Locations
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-
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Rehovot, Israel
- Recruiting
- Weizmann Institute of Science
-
Contact:
- Avner Leshem, MD
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Tel Aviv, Israel
- Recruiting
- Souraski medical center
-
Contact:
- Avner Leshem
- Phone Number: 97289346745
- Email: avner.leshem@weizmann.ac.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- candidates of bariatric surgery or cholecystectomy
- age 18-70
- male/female
Exclusion Criteria:
- previous bariatric surgery
- type 1 diabetes
- antibiotic treatment 3 months prior to the study
- probiotic treatment 3 months prior to the study
- chronic disease - gastrointestinal disease, malignancy, psychiatric disorder, endocrinologic disorders
- any pathologic findings during endoscopy
- participants who will suffer from a post-operation complication
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
sleeve gastrectomy surgery
participants undergoing sleeve gastrectomy surgery for weight reduction
|
participants undergoing sleeve gastrectomy surgery
|
|
gastric bypass surgery
participants undergoing gastric bypass surgery for weight reduction
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participants undergoing gastric bypass surgery
|
|
cholecystectomy
participants undergoing cholecystectomy
|
cholecystectomy
|
|
Pancreatectomy
participants undergoing Pancreatectomy
|
Collecting a sample of an unidentified healthy pancreas to extract insulin-secreting beta cells from the sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic response
Time Frame: up to 4 years
|
The glycemic response will be measured by taking a blood test (glucose) after 12 hours fast and a second blood test (glucose) after an OGTT(oral glucose tolerance test) of 50 g glucose
|
up to 4 years
|
|
microbiota composition
Time Frame: up to 4 years
|
The microbiota composition will be assessed using the stool samples of the participants.
|
up to 4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Avner Leshem, MD, Weizmann institute
- Principal Investigator: Danit Dayan, MD, Souraski medical center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0046-21-TLV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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