Glycemic Index Variations In the Early Period Following Bariatric Surgery

NCT04263168 | Withdrawn

• 1 other identifier: 6397-19-SMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The diverse community of gut microbes commonly referred to as the 'gut microbiome', is increasingly suggested to play significant roles in health and disease, and to affect even distant non-GI organs by metabolite signaling. Type 2 diabetes mellitus (T2DM) patients feature a distinct gut microbiome signature4, while modulating the gut microbiome by either antibiotics or fecal microbial transplantation (FMT) is suggested to impact insulin sensitivity. Originally designed to treat obesity, bariatric surgeries often induce a robust and rapid weight-independent improvement in glucose homeostasis within days. Early diabetes remission following bariatric surgery is hypothesized to be mediated by rapid alterations in the gut microbiome and bile acids composition, however, the exact mechanism is yet to be uncovered. Elucidating this mechanism is important as it may form the basis of a new therapeutic modality in diabetes. The investigators intend to deeply characterize early post-bariatric changes in the gut microbiome of diabetic patients, as well as their gut mucosal transcriptome and metabolome, by using state-of-the-art experimental and computational pipelines. Additionally, The investigators will utilize a unique mouse model of bariatric surgery under germ-free conditions, developed at the Elinav lab, that allows us to dissect the role of microbes in post-operative metabolic improvements.

Conditions

Diabetes Mellitus; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

• Changes in intestinal microbiota composition prior and following bariatric surgery

  Changes in intestinal microbiota composition following bariatric surgery measured with RNA sequencing

  two weeks

• Changes in glycemic index prior and following bariatric surgery

  Changes in glycemic index prior and following bariatric surgery measured with continues glucose monitoring system (FreeStyle Libre)

  two weeks

Study Arms (2)

Bariatric Surgery Candidates

EXPERIMENTAL

All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose monitoring system (CGM, Abbott 'freeStyle Libre').

Diagnostic Test: Continuous Glucose monitoring in the perioperative period

Laparoscopy Cholecystectomy

SHAM COMPARATOR

All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose monitoring system (CGM, Abbott 'freeStyle Libre').

Diagnostic Test: Continuous Glucose monitoring in the perioperative period

Interventions

Continuous Glucose monitoring in the perioperative period DIAGNOSTIC_TEST

All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose monitoring system (CGM, Abbott 'freeStyle Libre').

Bariatric Surgery Candidates; Laparoscopy Cholecystectomy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Population (\> 18 years old)
• Diabetic Patients (Type 2)
• Bariatric surgery candidates for two types of bariatric surgery, i.e. sleeve gastrectomy and Roux-en-Y gastric bypass
• Laparoscopic Cholecystectomy candidates

You may not qualify if:

• Pregnant Women
• \< 18 years old

Sponsors & Collaborators

• Sheba Medical Center: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Tel Aviv (Gosh Dan), 52561, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Bariatric surgery candidates for two types of bariatric surgery, i.e. sleeve gastrectomy (n=80) and Roux-en-Y gastric bypass (RYGB, n=80) will be recruited to the study from the bariatric surgery clinic in the Sheba medical center and will be followed pre- and postoperatively. A control group of candidates for another non-bariatric upper-GI surgery, i.e. cholecystectomy (n=80), will be recruited as well. All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose monitoring system (CGM, Abbott 'freeStyle Libre').

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: February 10, 2020
• Study Start: March 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)