Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
Location status: Recruiting
NCT Number: NCT02390973
Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Québec, Quebec, G1V 4G5, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: from baseline up to 60 months
percent of patient achieving type 2 diabetes remission in each groups
Time frame: from baseline up to 60 months
Normalisation of A/C ratio after surgery
Time frame: from baseline up to 60 months
Time frame: from baseline up yo 60 months
percent of patient achieving hypertension remission in each groups
Time frame: from baseline up to 60 months
percent of patient achieving gastro-esophageal reflux disease resolution in each groups
Time frame: from baseline up to 60 months
quality of life after surgery eveluated with questionnaires
Time frame: from baseline up to 60 months
percent of patient achieving sleep apnea remission in each groups
Time frame: from baseline up to 60 months
weight loss (kg)
Time frame: from baseline up to 60 months
regression of liver disease documented by percutaneous liver biopsy after surgery
Time frame: from baseline up to 60 months
percent of patient achieving dislipidemia remission in each groups
Time frame: baseline up to 4 month
comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification
Time frame: baseline up to 60 months
Vital status and long-term complications including cardiovascular events, micro- or macro-vascular complications, cancer, psychiatric events, bone fractures, operations, readmission related or unrelated to the surgery, changes in medical treatment will be compared between groups
Interested in participating?
Request InfoLaval University
Other
Acronym: REMISSION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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