Improvement in Glycemic Response After Bariatric Surgery

Bariatric Surgery Clinical Trial

Official title:

Improvement in Glycemic Response After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325736
• Other study ID #: 0046-21-TLV
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: Weizmann Institute of Science
• Contact: Avner Leshem, MD
• Phone: +972547487555
• Email: avner.leshem[@]weizmann.ac.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

decipher the role of microbiota in glycemic response change after bariatric surgery

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Procedure:
• sleeve gastrectomy surgery
participants undergoing sleeve gastrectomy surgery
• gastric bypass surgery
participants undergoing gastric bypass surgery
• control
cholecystectomy

Locations

Country	Name	City	State
Israel	Weizmann Institute of Science	Re?ovot
Israel	Souraski medical center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Weizmann Institute of Science	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	microbiota composition	The microbiota composition will be assessed using the stool samples of the participants.	up to 4 years