Weight-Loss Surgery vs Medical Management for Diabetes

(REMISSION Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Laval University

Must not be taking: Corticosteroids

Disqualifiers: Pregnancy, Past bariatric surgery, Severe disease, Alcohol abuse, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that the study will include diabetic patients treated with insulin, hypoglycemic agents, or diet, suggesting that some medications may be continued.

What data supports the effectiveness of the treatment Biliopancreatic Diversion with Duodenal Switch (BPD-DS) for diabetes?

Research shows that BPD-DS leads to better weight loss and improved blood sugar control compared to other surgeries like Roux-en-Y gastric bypass, especially in people with severe obesity. It also helps resolve type 2 diabetes more effectively than other bariatric procedures. ^{1 2 3 4 5}

Is weight-loss surgery safe for diabetes management?

Biliopancreatic diversion with duodenal switch (BPD/DS) is considered one of the most complex and highest risk weight-loss surgeries, with higher early postoperative risks compared to Roux-en-Y gastric bypass (RYGB). However, these risks may be influenced by patients having more health issues before surgery. ^{1 2 3 6 7}

How does the treatment Biliopancreatic Diversion with Duodenal Switch differ from other treatments for diabetes?

Biliopancreatic Diversion with Duodenal Switch (BPD-DS) is unique because it often leads to more significant weight loss and higher rates of diabetes remission compared to other surgeries like Roux-en-Y Gastric Bypass (RYGB). This treatment alters the digestive system more extensively, which may contribute to its effectiveness in improving glucose metabolism. ^{1 2 3 4 8}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

Your long-term blood sugar levels (HbA1c) are higher than 6.5%, or your fasting blood sugar levels are higher than 7mmol/l, or your non-fasting blood sugar levels are higher than 11mmol/l.

You have a body mass index (BMI) of 35 or higher.

Exclusion Criteria

I have a history of severe stomach issues, like unexplained vomiting or chronic diarrhea.

I have used corticosteroids in the past month.

You have used drugs or abused alcohol in the past year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bariatric surgery procedures (RYGB, SG, BPD-DS) or receive best medical management for diabetes

4 months

Multiple visits for surgery and post-operative care

Follow-up

Participants are monitored for long-term impact on metabolic, renal, and cardiovascular outcomes

60 months

Regular follow-up visits to assess remission rates and complications

Treatment Details

Interventions

• Biliopancreatic Diversion with Duodenal Switch (Procedure)
• Medical management (Other)
• Roux-en-Y Gastric Bypass (Procedure)
• Sleeve Gastrectomy (Procedure)

Trial Overview 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.

Participant Groups

Group I: Control Active Control 1 Intervention

the best medical management of their diabetes, non-surgical group

Group II: Roux-en-Y Gastric Bypass Active Control 1 Intervention

Group III: Biliopancreatic Diversion Active Control 1 Intervention

Group IV: Sleeve gastrectomy Active Control 1 Intervention

Biliopancreatic Diversion with Duodenal Switch is already approved in Canada for the following indications:

Approved in Canada as BPD-DS for:

• Severe obesity
• Type 2 diabetes

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Dr. Pedro O de Campos-Lima

Laval University

Chief Medical Officer since 1998

MD from Federal University of Juiz de Fora, PhD in Tumor Biology from Karolinska Institute

Dr. Manuel Caruso

Laval University

Chief Executive Officer since 1998

PhD in Virology from Pierre and Marie Curie University

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

Collaborator

Trials

26

Recruited

6,300+

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Collaborator

Trials

37

Recruited

9,700+

Johnson & Johnson Medical Products

Collaborator

Trials

1

Recruited

410+

Findings from Research

In a study comparing 30-day postoperative outcomes between biliopancreatic diversion with duodenal switch (BPD/DS) and Roux-En-Y gastric bypass (RYGB), matched cohorts of 5050 patients each showed that BPD/DS does not have higher early postoperative morbidity or mortality than RYGB.

The BPD/DS group had lower rates of surgical-site infections and blood transfusions compared to the RYGB group, suggesting that BPD/DS may be as safe as RYGB in the short term when accounting for baseline health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duodenal switch versus Roux-en-Y gastric bypass: a perioperative risk comparative analysis of the MBSAQIP Database (2015-2019). Clapp, B., Mehta, K., Corbett, J., et al.[2022]

In a study of 47 severely obese patients (BMI >48 kg/m²), biliopancreatic diversion with duodenal switch (BPD/DS) resulted in significantly greater weight loss and lower blood sugar levels compared to Roux-en-Y gastric bypass (RYGB) after 3 years.

Both surgical procedures were safe, but BPD/DS had longer surgery times and higher postoperative morphine use, and while it led to more reports of diarrhea, the difference was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior weight loss and lower HbA1c 3 years after duodenal switch compared with Roux-en-Y gastric bypass--a randomized controlled trial. Hedberg, J., Sundbom, M.[2022]

The duodenal switch/biliopancreatic diversion (DS/BD) procedure leads to greater improvements in comorbid conditions like type 2 diabetes, hypertension, and hyperlipidemia compared to Roux-en-Y gastric bypass (RYGB), despite similar overall weight loss between the two groups.

While DS/BD patients reported more frequent loose stools and bloating, the overall complication rates were comparable to those of RYGB, indicating that DS/BD is a safe and effective option for significant health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits and complications of the duodenal switch/biliopancreatic diversion compared to the Roux-en-Y gastric bypass. Dorman, RB., Rasmus, NF., al-Haddad, BJ., et al.[2021]

Biliopancreatic diversion with duodenal switch (BPD/DS) significantly reduces weight gain and fat accumulation in nonobese rats, primarily due to food malabsorption caused by the duodenal switch component.

The surgery also increases levels of appetite-suppressing hormones GLP-1 and PYY, which contribute to its metabolic benefits, while sleeve gastrectomy alone does not produce these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malabsorption plays a major role in the effects of the biliopancreatic diversion with duodenal switch on energy metabolism in rats. Li, W., Baraboi, ED., Cluny, NL., et al.[2015]

Biliopancreatic diversion with duodenal switch (BPD/DS) resulted in an impressive average weight loss of 85% of excess body weight after one year, making it one of the most effective bariatric procedures.

Despite its effectiveness, BPD/DS is associated with longer surgery times and higher complication rates compared to laparoscopic gastric bypass, including issues like gastric sleeve leaks and small bowel obstructions, but without severe malnutrition risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early results after introduction of biliopancreatic diversion/duodenal switch at a military bariatric center. Nelson, D., Beekley, A., Carter, P., et al.[2011]

In a study of 460 patients undergoing either biliopancreatic diversion with duodenal switch (BPD-DS) or single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), BPD-DS resulted in greater total body weight loss (TBWL) at 2 years, but both procedures had similar overall complication rates (14% for BPD-DS vs 18% for SADI-S).

SADI-S had a shorter operative time compared to BPD-DS (140.85 minutes vs 167.25 minutes), but it also led to more emergency department visits (17% vs 7%), indicating a potential trade-off between quicker surgery and post-operative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. Lind, RP., Ghanem, M., Teixeira, AF., et al.[2022]

Biliopancreatic diversion (BPD) surgery results in a higher rate of diabetes remission compared to Roux-en-Y gastric bypass (RYGB).

The study highlights that the gut plays a significant role in the differing effects of these two surgical procedures, suggesting that the mechanisms of action may vary based on the type of surgery performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Gut Check Explains Improved Glucose Metabolism after Surgery. Laferrère, B., Pattou, F.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Duodenal switch versus Roux-en-Y gastric bypass: a perioperative risk comparative analysis of the MBSAQIP Database (2015-2019). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term resolution of type 2 diabetes after biliopancreatic diversion and duodenal switch procedure: a retrospective analysis from a high-volume institution. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Superior weight loss and lower HbA1c 3 years after duodenal switch compared with Roux-en-Y gastric bypass--a randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Benefits and complications of the duodenal switch/biliopancreatic diversion compared to the Roux-en-Y gastric bypass. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Malabsorption plays a major role in the effects of the biliopancreatic diversion with duodenal switch on energy metabolism in rats. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Early results after introduction of biliopancreatic diversion/duodenal switch at a military bariatric center. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Gut Check Explains Improved Glucose Metabolism after Surgery. [2023]