Improvement in Glycemic Response After Bariatric Surgery
1 other identifier
observational
120
1 country
2
Brief Summary
decipher the role of microbiota in glycemic response change after bariatric surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
March 26, 2025
March 1, 2025
5 years
February 10, 2022
March 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Glycemic response
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
The microbiota composition will be assessed using the stool samples of the participants.
up to 4 years
Study Arms (4)
sleeve gastrectomy surgery
participants undergoing sleeve gastrectomy surgery for weight reduction
gastric bypass surgery
participants undergoing gastric bypass surgery for weight reduction
cholecystectomy
participants undergoing cholecystectomy
Pancreatectomy
participants undergoing Pancreatectomy
Interventions
participants undergoing sleeve gastrectomy surgery
Collecting a sample of an unidentified healthy pancreas to extract insulin-secreting beta cells from the sample
Eligibility Criteria
patients arriving at the outpatient unit at Tel Aviv Sourasky medical center
You may qualify if:
- candidates of bariatric surgery or cholecystectomy
- age 18-70
- male/female
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weizmann Institute of Sciencelead
- Tel-Aviv Sourasky Medical Centercollaborator
Study Sites (2)
Weizmann Institute of Science
Rehovot, Israel
Souraski medical center
Tel Aviv, Israel
Biospecimen
stool, serum
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Avner Leshem, MD
Weizmann institute
- PRINCIPAL INVESTIGATOR
Danit Dayan, MD
Souraski medical center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2022
First Posted
April 13, 2022
Study Start
July 1, 2021
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
March 26, 2025
Record last verified: 2025-03