Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLaval University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≥ 35

type 2 diabetes

HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l

able to consent

Disqualifiers

pregnancy

past esophageal, gastric or bariatric surgery

irritable bowel, unexplained intermittent vomiting, severe abdominal pain, chronic diarrhea or constipation

history of gastric or duodenal ulcers

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleeve Gastrectomy

    Procedure/Surgery
  • Roux-en-Y Gastric Bypass

    Procedure/Surgery
  • Biliopancreatic Diversion with Duodenal Switch

    Procedure/Surgery
  • Medical management

    Other intervention

Treatment groups

408 Participants
are divided into 4 treatment groups
Group A: Sleeve gastrectomyActive comparator 1 intervention
Group B: Roux-en-Y Gastric BypassActive comparator 1 intervention
Group C: Biliopancreatic DiversionActive comparator 1 intervention
Group D: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Type 2 diabetes remission rate

percent of patient achieving type 2 diabetes remission in each groups

Time frame
from baseline up to 60 months

Secondary outcomes

1

Change in microalbuminuria

Normalisation of A/C ratio after surgery

Time frame
from baseline up to 60 months
2

Change in retinopathy

Time frame
from baseline up to 60 months
3

Hypertension remission rate

percent of patient achieving hypertension remission in each groups

Time frame
from baseline up yo 60 months
4

GERD remission rate

percent of patient achieving gastro-esophageal reflux disease resolution in each groups

Time frame
from baseline up to 60 months

Other outcomes

1

short-term complications

comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification

Time frame
baseline up to 4 month
2

Long-term complications

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

Time frame
baseline up to 60 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Johnson & Johnson Medical Products

Collaborator

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

Collaborator