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Procedure

Bariatric Surgery for Type 2 Diabetes (CB5 Trial)

N/A

Recruiting

Led By André Carpentier, MD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 to 65

Diagnosed T2D - according to Diabetes Canada diagnostics criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured after liquid meal at baseline (a0 +a1), at day 12 (b0) and at week 52 (c0)

Awards & highlights

CB5 Trial Summary

This trial will study whether bariatric surgery helps reduce T2D by studying changes in fat tissue metabolism.

Who is the study for?

This trial is for adults aged 18-65 with a BMI of at least 35 kg/m2, who have Type 2 Diabetes or do not have diabetes, as per Diabetes Canada's criteria. It excludes those with serious heart, liver, or kidney diseases; on certain medications like oral contraceptives and insulin; smokers; heavy drinkers; pregnant or breastfeeding women; and anyone allergic to eggs.Check my eligibility

What is being tested?

The study investigates the effect of bariatric surgery on metabolic function in fat tissue and its role in remission of Type 2 Diabetes. Participants will undergo surgery and are divided into two groups: one with diabetes (T2D) and one without (non-T2D).See study design

What are the potential side effects?

Potential side effects from bariatric surgery can include nutritional deficiencies, digestive issues such as nausea and vomiting, surgical complications like infections or bleeding, changes in bowel habits, and possible need for reoperation.

CB5 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with Type 2 Diabetes.

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I am a woman and my pregnancy test was negative.

CB5 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured after liquid meal at baseline (a0 +a1), at day 12 (b0) and at week 52 (c0)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured after liquid meal at baseline (a0 +a1), at day 12 (b0) and at week 52 (c0)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured after liquid meal at baseline (a0 +a1), at day 12 (b0) and at week 52 (c0) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Endogenous Glucose production and meal glucose systemic flux

Change in cardiac non-esterified fatty acid (NEFA) uptake, oxidation and esterification

Change in lean organ (liver, heart and muscle) DFA uptake and partitioning

+2 more

Secondary outcome measures

Change in gene and protein expression of white adipose tissue (WAT)

Change in glycerol turnover

Change in hepatic Triglyceride (TG) content

+8 more

CB5 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: group with Type 2 diabetesExperimental Treatment2 Interventions

with T2D according to Diabetes Canada diagnostics criteria:

Group II: Control groupActive Control2 Interventions

without T2D according to Diabetes Canada diagnostics criteria:

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bariatric surgery

2013

Completed Phase 4

~15460

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor

293 Previous Clinical Trials

69,475 Total Patients Enrolled

Institut universitaire de cardiologie et de pneumologie de Québec, University LavalOTHER

18 Previous Clinical Trials

3,443 Total Patients Enrolled

Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER

58 Previous Clinical Trials

31,125 Total Patients Enrolled

Media Library

Bariatric surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05934409 — N/A

Type 2 Diabetes Research Study Groups: Control group, group with Type 2 diabetes

Type 2 Diabetes Clinical Trial 2023: Bariatric surgery Highlights & Side Effects. Trial Name: NCT05934409 — N/A

Bariatric surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05934409 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there eligibility for me to participate in this clinical trial?

"To gain admission into this medical trial, applicants must have type 2 diabetes and should be in the 18-65 year old age bracket. Approximately 40 spots are available for successful candidature."

Answered by AI

Can individuals aged 60 or over participate in this research endeavor?

"As outlined in the study's guidelines, only individuals aged 18 to 65 are eligible for enrolment. There are 41 trials available specifically designed for minors and 679 open studies catered towards seniors."

Answered by AI

What are the intended results of this medical experiment?

"The main result of this medical study, which will be measured at the start (A0 + A1), midpoint (B0) and conclusion (C0), is to track alterations in lean organ uptake and compartmentalisation via Deuterium Flux Analysis. Other objectives encompass modifications in hepatic triglyceride content observed through Magnetic Resonance Imaging scans, changes in insulin secretion monitored by C-peptide kinetics following a liquid meal, and fluctuations in total substrate utilisation captured by indirect calorimetry."

Answered by AI

Is this medical trial still open for recruitment?

"According to clinicaltrials.gov, this particular trial has stopped recruiting patients as of June 27th 2023; initially posted on September 1st 2022. Fortunately, there are still 778 other trials actively looking for volunteers at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery

André Carpentier 2023. "Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05934409.