Bariatric Surgery for Type 2 Diabetes

(CB5 Trial)

Overseen By Frédérique Frisch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Oral contraceptives, Fibrates, Insulin, others

Disqualifiers: Cardiovascular disease, Liver failure, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether weight-loss surgery (bariatric surgery) can improve or even reverse Type 2 Diabetes (T2D) by examining changes in body fat. Participants will be divided into two groups: one with T2D and one without, to observe each group's response to the surgery. The trial suits individuals diagnosed with T2D or those meeting the criteria for not having it, who have a BMI of 35 or more, and are considering surgery to manage their weight and health. As an unphased study, this trial offers participants a unique opportunity to contribute to groundbreaking research on the impact of bariatric surgery on diabetes.

Will I have to stop taking my current medications?

The trial requires that participants temporarily stop taking certain medications for diabetes, lipids, or hypertension. If you are on medications like fibrate, thiazolidinedione, insulin, or beta-blockers, you may not be eligible to participate.

What prior data suggests that this protocol is safe for participants?

Research shows that weight-loss surgery is generally safe for individuals with and without type 2 diabetes. Studies have confirmed the long-term safety of two common types of weight-loss surgery: Roux-en-Y gastric bypass and sleeve gastrectomy. For example, one study found no deaths directly linked to the surgery, even 15 years later. Another study demonstrated that these surgeries helped individuals lose weight and manage diabetes better, without major safety concerns. While any surgery carries risks, weight-loss surgery overall has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Bariatric surgery is unique because it tackles Type 2 diabetes by addressing the root cause—excess weight—rather than just managing symptoms like most medications do. Researchers are excited about this treatment because it can lead to significant and sustained weight loss, which in turn can improve blood sugar control and even lead to remission of diabetes in some patients. Unlike standard treatments such as insulin or oral medications, bariatric surgery offers a potential long-term solution, reducing the need for daily medication and the risk of diabetes-related complications.

What evidence suggests that bariatric surgery could be effective for Type 2 Diabetes?

This trial will compare the effects of bariatric surgery, specifically Roux-en-Y gastric bypass, on patients with Type 2 Diabetes (T2D) to those without T2D. Research has shown that weight-loss surgery can effectively treat T2D. Studies indicate that Roux-en-Y gastric bypass often results in better long-term diabetes remission, meaning symptoms disappear, and improved blood sugar control compared to other procedures. Patients frequently lose significant weight, which also aids in managing diabetes. Long-term evidence demonstrates that many patients maintain better diabetes control even years after surgery, suggesting a strong connection between weight-loss surgery and improved diabetes outcomes. ^{4 6 7 8 9}

Who Is on the Research Team?

André Carpentier, MD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a BMI of at least 35 kg/m2, who have Type 2 Diabetes or do not have diabetes, as per Diabetes Canada's criteria. It excludes those with serious heart, liver, or kidney diseases; on certain medications like oral contraceptives and insulin; smokers; heavy drinkers; pregnant or breastfeeding women; and anyone allergic to eggs.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

I am a woman and my pregnancy test was negative.

Your body mass index (BMI) is higher than 35.

Exclusion Criteria

I am currently taking birth control pills.

You have an allergy to eggs.

I cannot stop my diabetes, cholesterol, or blood pressure medicine for surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Pre-Surgery Metabolic Sessions

Participants undergo two metabolic sessions (A0 and A1) with and without niacin, in random order, at least one week apart.

2 weeks

2 visits (in-person)

Post-Surgery Metabolic Session

Participants undergo a metabolic session (B0) 12 days after surgery without niacin.

1 day

1 visit (in-person)

Long-term Follow-up Metabolic Session

Participants undergo a metabolic session (C0) 1 year after surgery without niacin.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bariatric surgery
• Nicotinic Acid

Trial Overview

The study investigates the effect of bariatric surgery on metabolic function in fat tissue and its role in remission of Type 2 Diabetes. Participants will undergo surgery and are divided into two groups: one with diabetes (T2D) and one without (non-T2D).

How Is the Trial Designed?

Group I: group with Type 2 diabetes Experimental Treatment 2 Interventions

with T2D according to Diabetes Canada diagnostics criteria:

Group II: Control group Active Control 2 Interventions

without T2D according to Diabetes Canada diagnostics criteria:

Bariatric surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gastric Sleeve Surgery for:

• Severe Obesity
• Obesity-related conditions such as type 2 diabetes, high blood pressure, and sleep apnea

Approved in European Union as Sleeve Gastrectomy for:

• Morbid Obesity
• Obesity-related comorbidities

Approved in Canada as Bariatric Surgery for:

• Class III Obesity
• Obesity-related health issues

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

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

Collaborator

Trials

26

Recruited

6,300+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

Published Research Related to This Trial

Laparoscopic sleeve gastrectomy is a highly effective and safe surgical option for treating obesity and type 2 diabetes mellitus, making it a popular choice in bariatric surgery.

The review highlights the significant efficacy of this procedure, indicating its growing acceptance and application in the field of metabolic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the application of laparoscopic sleeve gastrectomy in bariatric and metabolic surgery]. Xu, B., Yao, QY.[2018]

From 2012 to 2015, sleeve gastrectomy (SG) became the most common bariatric procedure in the USA, increasing from 38% to 63%, while Roux-en-Y gastric bypass (RYGB) usage decreased from 44% to 30%.

SG is associated with lower readmission rates compared to RYGB (odds ratio 0.64) and is also less expensive ($11,183 for SG vs. $13,485 for RYGB), making it a more favorable option for patients, especially those with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Trends in Bariatric Surgery 2012-2015: Demographics, Procedure Selection, Readmissions, and Cost. Kizy, S., Jahansouz, C., Downey, MC., et al.[2022]

In a study of 984 patients who underwent laparoscopic sleeve gastrectomy (LSG), those with type 2 diabetes mellitus (T2DM) experienced a higher rate of mild complications (13.3%) compared to non-T2DM patients (7.0%), indicating a need for careful monitoring in this group.

An increase in hemoglobin A1c levels was linked to a significantly higher risk of severe complications (40.7% increase per 1% rise), suggesting that better pre-operative management of blood sugar levels may improve safety outcomes for T2DM patients undergoing LSG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New results on the safety of laparoscopic sleeve gastrectomy bariatric procedure for type 2 diabetes patients. Guetta, O., Vakhrushev, A., Dukhno, O., et al.[2020]

Laparoscopic sleeve gastrectomy (LSG) led to significant weight loss (average excess weight loss of 60.75%) and resulted in a 78.9% remission rate of type 2 diabetes mellitus (T2DM) in a study of 104 obese patients over 6 months.

Younger patients with less severe diabetes and shorter disease duration had better chances of remission after LSG, suggesting that this surgery is most effective when performed earlier in the disease process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Determining Diabetic Remission after Sleeve Gastrectomy: A Prospective Study. Jindal, R., Gupta, M., Ahuja, A., et al.[2022]

Both laparoscopic gastric bypass and laparoscopic sleeve gastrectomy effectively reduced BMI and improved diabetic conditions in overweight and obese patients with type-2 diabetes, with significant improvements in various metabolic markers post-surgery.

Laparoscopic sleeve gastrectomy was associated with shorter surgery times and less intraoperative blood loss compared to gastric bypass, making it a potentially safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of laparoscopic gastric bypass vs laparoscopic sleeve gastrectomy in treating obesity combined with type-2 diabetes. Yan, Y., Wang, F., Chen, H., et al.[2022]

In a study of 38,153 bariatric surgery patients, sleeve gastrectomy was associated with fewer re-interventions (9.9% vs. 15.6%) and complications (6.6% vs. 9.6%) compared to gastric bypass after 2 years, indicating a better safety profile for sleeve gastrectomy.

Despite its overall safety advantages, sleeve gastrectomy had a slightly higher rate of revisions (0.6% vs. 0.4%) compared to gastric bypass, suggesting that while it is safer, the risk of needing further surgery should be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach. Chhabra, KR., Telem, DA., Chao, GF., et al.[2022]

Laparoscopic sleeve gastrectomy (LSG) is a safe and effective treatment for obesity in patients with type 2 diabetes mellitus (T2DM), with no major complications reported in a study of 32 patients over 12 months.

The procedure led to significant weight loss and improvements in blood glucose levels, with an 87.5% complete remission rate of T2DM observed at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of laparoscopic sleeve gastrectomy in treatment of obesity with type 2 diabetes mellitus]. Chang, X., Zheng, C., Wang, X., et al.[2022]

A systematic review of 27 studies involving 673 patients showed that laparoscopic sleeve gastrectomy (LSG) led to a significant resolution of type 2 diabetes mellitus (DM) in 66.2% of patients, with 26.9% experiencing improvement in their condition.

Patients had an average excess weight loss of 47.3% after LSG, and notable decreases in blood glucose levels (-88.2 mg/dL) and hemoglobin A1c (-1.7%) were observed, indicating LSG's potential as an effective metabolic therapy for type 2 DM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy and type 2 diabetes mellitus: a systematic review. Gill, RS., Birch, DW., Shi, X., et al.[2022]

In a 4-month study involving 85 severely obese subjects with type 2 diabetes, both sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) resulted in similar weight loss and resolution rates of diabetes, with 51.4% for SG and 62.0% for RYGB.

The study suggests that factors beyond just weight loss, such as preoperative diabetes duration and treatment type, play a significant role in the resolution of type 2 diabetes after these surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of sleeve gastrectomy on type 2 diabetes mellitus in severely obese subjects. Vidal, J., Ibarzabal, A., Nicolau, J., et al.[2021]

In a study of 6062 patients who underwent laparoscopic sleeve gastrectomy (LSG), type 2 diabetics (T2DM) showed no increased risk of 30-day complications compared to non-diabetic patients, indicating that LSG is a safe option for this population.

While T2DM patients had a slightly higher rate of blood transfusions post-surgery, the overall complication rate was similar to non-diabetics, and type 1 diabetics experienced higher complication rates than both T2DM and non-diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of laparoscopic sleeve gastrectomy among diabetic patients. Creange, C., Sethi, M., Fielding, G., et al.[2018]

In a study of 35 patients with type 2 diabetes, both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SLG) led to significant improvements in diabetes remission, with 13 patients from RYGB and 7 from SLG achieving remission.

Key factors for diabetes remission included baseline β-cell glucose sensitivity and an improved GLP-1 response after surgery, indicating that these hormonal changes are crucial for the effectiveness of the surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roux-en-Y gastric bypass and sleeve gastrectomy: mechanisms of diabetes remission and role of gut hormones. Nannipieri, M., Baldi, S., Mari, A., et al.[2013]

Laparoscopic sleeve gastrectomy (LSG) is a safe and effective treatment for type 2 diabetes mellitus (T2DM) in patients with a body mass index (BMI) less than 35 kg/m2, showing promising short-term results.

Patients with a BMI between 30-34.9 kg/m2 experienced significantly higher complete remission rates of T2DM (88.5% at 12 months) compared to those with a BMI less than 30 kg/m2 (15.4% at 12 months), indicating that LSG may be more effective in patients with higher BMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy comparison of laparoscopic sleeve gastrectomy in type 2 diabetes patients with a BMI 30-34.9 kg/m2 versus BMI < 30 kg/m2. Wu, D., Wang, L., Jiang, T.[2021]

In a study of 109 patients with obesity and type 2 diabetes, gastric bypass surgery resulted in significantly greater improvements in weight-related quality of life, weight loss (25% vs 17%), and diabetes remission (67% vs 33%) compared to sleeve gastrectomy after 3 years.

Gastric bypass also led to fewer reflux symptoms compared to sleeve gastrectomy, while both procedures showed similar rates of other complications like abdominal pain and depression, providing valuable insights for patient decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial. Svanevik, M., Lorentzen, J., Borgeraas, H., et al.[2023]

In a study of 32 obese patients with type 2 diabetes mellitus (T2DM) who underwent transit bipartition with sleeve gastrectomy (TB-SG), 84.3% achieved remission of T2DM after 36 months, indicating high efficacy for glycemic control.

The procedure resulted in significant weight loss, with a mean body mass index (BMI) reduction from 44.70 to 29.75 kg/m2, while maintaining stable nutritional levels, suggesting it is a safe option with minimal risk of malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mid-Term Effects of Transit Bipartition with Sleeve Gastrectomy on Glycemic Control, Weight Loss, and Nutritional Status in Patients with Type 2 Diabetes Mellitus: a Retrospective Analysis of a 3-Year Follow-up. Calisir, A., Ece, I., Yilmaz, H., et al.[2022]

In a study of 150 obese patients with uncontrolled type 2 diabetes, those who underwent bariatric surgery (either gastric bypass or sleeve gastrectomy) achieved significantly better glycemic control after 12 months compared to those receiving only medical therapy, with 42% and 37% reaching a glycated hemoglobin level of 6.0% or less, respectively.

Bariatric surgery also led to greater weight loss and a significant reduction in the need for diabetes medications, while the medical therapy group experienced an increase in medication use, highlighting the superior efficacy of surgical interventions for managing type 2 diabetes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric surgery versus intensive medical therapy in obese patients with diabetes. Schauer, PR., Kashyap, SR., Wolski, K., et al.[2022]

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