Weight-Loss Surgery vs Medical Management for Diabetes

(REMISSION Trial)

Overseen By Melanie Nadeau, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Corticosteroids

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

408 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how three types of weight-loss surgeries—Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and Biliopancreatic Diversion with Duodenal Switch—affect type 2 diabetes, focusing on long-term health impacts. Researchers compare the effects of these surgeries on metabolism, kidney, and heart health against the best non-surgical diabetes treatments (medical management). It is ideal for individuals who are severely obese, have type 2 diabetes, and struggle with blood sugar levels, meeting specific health criteria. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future diabetes treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the three weight-loss surgeries under study—Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Biliopancreatic Diversion with Duodenal Switch (BPD-DS)—have different safety profiles.

For BPD-DS, studies suggest it is highly effective for weight loss and improving type 2 diabetes. However, it carries risks such as malnutrition and vitamin deficiencies. These side effects can be managed but are important to consider before choosing this surgery.

RYGB has also demonstrated strong results for weight loss and diabetes improvement. Research indicates that RYGB leads to significant long-term weight loss and maintains diabetes control for many years. While no major safety concerns have been reported, there are some risks, as with any surgery.

SG is linked to significant improvements in diabetes control and weight loss, especially in the first year. It has a lower risk of surgical complications compared to RYGB and BPD-DS. However, it may not be as effective for long-term diabetes control in some individuals.

Overall, while these surgeries offer benefits, they can also have side effects. It's important to weigh these risks and benefits when considering these options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard approach of managing diabetes with medications and lifestyle changes, weight-loss surgeries like Biliopancreatic Diversion with Duodenal Switch, Roux-en-Y Gastric Bypass, and Sleeve Gastrectomy offer unique benefits. These surgical options can lead to significant and sustained weight loss, which not only helps with diabetes control but may also lead to remission in some patients. Researchers are excited because these procedures tackle the root cause of type 2 diabetes by altering the digestive system, which improves insulin sensitivity and glucose metabolism. This approach has the potential to provide longer-term relief compared to traditional medical management.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

This trial will compare the effectiveness of different weight-loss surgeries and medical management for treating type 2 diabetes. Participants may receive Biliopancreatic Diversion with Duodenal Switch (BPD-DS), Roux-en-Y Gastric Bypass (RYGB), or Sleeve Gastrectomy (SG), or they may be part of the control group receiving the best medical management. Research has shown that BPD-DS is particularly effective, with 97% of patients experiencing improvement or remission of their diabetes. RYGB has proven successful in the long term, maintaining diabetes remission for up to 15 years. SG also aids in diabetes management, with 66.2% of patients experiencing resolution. These surgeries not only help manage diabetes but also lead to significant weight loss and improved overall health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as BPD-DS for:

• Severe obesity
• Type 2 diabetes

Approved in United States as BPD-DS for:

• Severe obesity
• Type 2 diabetes

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+

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+

Published Research Related to This Trial

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]

In a study of 151 patients who underwent biliopancreatic diversion with duodenal switch (BPD-DS) for type 2 diabetes, 98.1% experienced either partial or complete resolution of their diabetes after surgery, indicating a highly effective intervention.

The long-term follow-up data, with over 5 years available for 51% of patients, suggests that BPD-DS not only leads to significant weight loss but also provides substantial and lasting improvements in diabetes management.

NCBI (Pubmed)

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. Goriparthi, RG., Martins, A., Yerragorla, P., et al.[2022]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728924009109

Biliopancreatic diversion with duodenal switch results in ... BPD/DS was found to be a superior procedure in achieving sustained weight loss and diabetes remission in patients with BMI ≥50.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6444525/

Biliopancreatic Diversion with Duodenal Switch in Patients ... Rapid resolution of type 2 diabetes mellitus (T2DM) is a common feature after intestinal bypass surgery bypassing the duodenum and parts of the jejunum.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687107/

Remission of Type II Diabetes Mellitus after Duodenal Switch When the AL is fixed, shortening CC lengths results in improved glycemic control and remission of DM in patients with the need for insulin preoperatively.

4. asmbs.org asmbs.org/condition_procedures/biliopancreatic-diversion-with-duodenal-switch/

Biliopancreatic Diversion with Duodenal Switch The BPD-DS is considered to be the most effective approved metabolic operation for the treatment of type 2 diabetes. Advantages. Among the best results for ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728922001812

Long-term resolution of type 2 diabetes after ... Long-term glycemic outcomes after BPD-DS are favorable, with 97% of patients experiencing either complete or partial remission or improvement.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728922007237

Long-term outcome after biliopancreatic diversion with ... BPD/DS offers a sustainable long-term weight loss, but is associated with important side effects that may be acceptable in selected patients with a high initial ...

7. mayoclinic.org mayoclinic.org/tests-procedures/biliopancreatic-diversion-with-duodenal-switch/about/pac-20385180

Biliopancreatic diversion with duodenal switch (BPD/DS) While a BPD/DS is very effective, it has risks, including malnutrition and vitamin deficiencies. This procedure is generally recommended for ...

8. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.934434/full

First study on the outcomes of biliopancreatic diversion ... Conclusion: BPD-DS had excellent weight loss and resolution of comorbidities among Chinese patients with obesity. However, high rates of nutritional ...