Bariatric SurgeryNCT05325736
Improvement in Glycemic Response After Bariatric Surgery
An observational study of Bariatric Surgery, run by Weizmann Institute of Science at 2 sites in Israel.
Trial summary
decipher the role of microbiota in glycemic response change after bariatric surgery Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- sleeve gastrectomy surgery, gastric bypass surgery and Pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jul 2021to 1 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients arriving at the outpatient unit at Tel Aviv Sourasky medical center
Who may be able to join
- candidates of bariatric surgery or cholecystectomy
- age 18-70
- male/female
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Weizmann Institute of Science
Rehovot
Avner Leshem, MD
- Recruiting
Souraski medical center
Tel Aviv
Avner Leshem, 97289346745, avner.leshem@weizmann.ac.il
About this study
decipher the role of microbiota in glycemic response change after bariatric surgery
Read the 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.
- Conditions
- Bariatric Surgery
- Being tested
- sleeve gastrectomy surgery, gastric bypass surgery, control, Pancreatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomy surgeryProcedure or surgery
participants undergoing sleeve gastrectomy surgery
gastric bypass surgeryProcedure or surgery
participants undergoing gastric bypass surgery
controlProcedure or surgery
cholecystectomy
PancreatectomyProcedure or surgery
Collecting a sample of an unidentified healthy pancreas to extract insulin-secreting beta cells from the sample
| Study group | Role | What they receive |
|---|---|---|
| sleeve gastrectomy surgery | participants undergoing sleeve gastrectomy surgery for weight reduction Receives: Procedure: sleeve gastrectomy surgery | |
| gastric bypass surgery | participants undergoing gastric bypass surgery for weight reduction Receives: Procedure: gastric bypass surgery | |
| cholecystectomy | participants undergoing cholecystectomy Receives: Procedure: control | |
| Pancreatectomy | participants undergoing Pancreatectomy Receives: Procedure: Pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 years
microbiota composition
The microbiota composition will be assessed using the stool samples of the participants.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Jul 2021
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
- Investigators
- Avner Leshem, MD, Study director, Weizmann instituteDanit Dayan, MD, Principal investigator, Souraski medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325736
- Sponsor's protocol ID
- 0046-21-TLV
- Status last verified
- May 2026
- First submitted
- 10 Feb 2022
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Glycemic Response After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05325736
- Acronym / sponsor ID
- 0046-21-TLV
- Conditions
- Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
decipher the role of microbiota in glycemic response change after bariatric surgery
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sleeve gastrectomy surgery | – | Procedure: sleeve gastrectomy surgeryparticipants undergoing sleeve gastrectomy surgery for weight reduction |
| gastric bypass surgery | – | Procedure: gastric bypass surgeryparticipants undergoing gastric bypass surgery for weight reduction |
| cholecystectomy | – | Procedure: controlparticipants undergoing cholecystectomy |
| Pancreatectomy | – | Procedure: Pancreatectomyparticipants undergoing Pancreatectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients arriving at the outpatient unit at Tel Aviv Sourasky medical center
Key inclusion criteria (3 listed)
- candidates of bariatric surgery or cholecystectomy
- age 18-70
- male/female
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleeve gastrectomy surgeryparticipants undergoing sleeve gastrectomy surgery | Procedure or surgery | sleeve gastrectomy surgery |
| gastric bypass surgeryparticipants undergoing gastric bypass surgery | Procedure or surgery | gastric bypass surgery |
| controlcholecystectomy | Procedure or surgery | cholecystectomy |
| PancreatectomyCollecting a sample of an unidentified healthy pancreas to extract insulin-secreting beta cells from the sample | Procedure or surgery | Pancreatectomy |
Primary outcome
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
microbiota composition
Time frame: up to 4 years
The microbiota composition will be assessed using the stool samples of the participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avner Leshem, MD study director
Weizmann institute
Danit Dayan, MD principal investigator
Souraski medical center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Weizmann Institute of Science at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avner Leshem, MD (+972547487555, avner.leshem@weizmann.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic response (time frame: up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.