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Weight-Loss Surgery vs Medical Management for Diabetes (REMISSION Trial)

N/A
Recruiting
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of type 2 diabetes
Be between 18 and 65 years old
Must not have
History of irritable bowel, unexplained intermittent vomiting, severe abdominal pain, chronic diarrhea, or constipation
History of gastrointestinal inflammatory diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the long-term effects of 3 different weight-loss surgeries on diabetes, kidney, and heart health in obese patients with diabetes.

Who is the study for?
This trial is for individuals with type 2 diabetes, an HbA1c ≥ 6.5%, fasting glycemia ≥ 7mmol/l or non-fasting glycemia ≥ 11mmol/l, and a BMI ≥ 35 who can consent to participate. It excludes those with recent substance abuse, pregnancy, certain gastrointestinal diseases, prior gastric surgeries, severe organ disease, corticosteroid use in the last month, or psychological issues affecting compliance.
What is being tested?
The REMISSION trial is studying the long-term effects of three bariatric surgery types (RYGB, SG & BPD-DS) on metabolic recovery and quality of life compared to best medical management in diabetic patients. The goal is to understand which procedure might be most beneficial for treating type 2 diabetes.
What are the potential side effects?
Potential side effects from these surgeries include nutritional deficiencies due to malabsorption, surgical complications like infections or bleeding, changes in bowel habits such as diarrhea or constipation and possible need for reoperation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of severe stomach issues, like unexplained vomiting or chronic diarrhea.
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I have had inflammatory bowel disease.
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I have had stomach or duodenal ulcers in the past.
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I have had surgery on my esophagus, stomach, or weight loss surgery.
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I have a history of serious kidney, liver, heart, or lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Type 2 diabetes remission rate
Secondary study objectives
Change in microalbuminuria
Dislipidemia remission
GERD remission rate
+5 more
Other study objectives
Long-term complications
short-term complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
the best medical management of their diabetes, non-surgical group
Group II: Roux-en-Y Gastric BypassActive Control1 Intervention
Group III: Biliopancreatic DiversionActive Control1 Intervention
Group IV: Sleeve gastrectomyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University LavalOTHER
22 Previous Clinical Trials
3,835 Total Patients Enrolled
1 Trials studying Bariatric Surgery Candidates
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
36 Previous Clinical Trials
9,327 Total Patients Enrolled
Laval UniversityLead Sponsor
431 Previous Clinical Trials
178,029 Total Patients Enrolled
3 Trials studying Bariatric Surgery Candidates
10,040 Patients Enrolled for Bariatric Surgery Candidates
~10 spots leftby Mar 2025
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