Gastric Bypass vs. Diet for Type 2 Diabetes

(RBD-T2D Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Metabolic medications

Disqualifiers: Tobacco use, Pregnancy, Organ dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares weight loss from surgery and dieting in obese people, some with diabetes. Both methods aim to improve how the body processes sugar and overall health by significantly reducing body weight.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it excludes those using medications that might affect metabolic function. It's best to discuss your specific medications with the trial team.

Is Roux-en-Y gastric bypass safe for humans?

Roux-en-Y gastric bypass (RYGB) is generally considered safe and has been widely studied, but it can lead to risks like malnutrition and vitamin deficiencies, so careful monitoring is important. ^{1 2 3 4 5}

How does the treatment of Roux-en-Y Gastric Bypass differ from other treatments for type 2 diabetes?

Roux-en-Y Gastric Bypass (RYGB) is unique because it can improve type 2 diabetes even in patients who are not significantly overweight, by altering the digestive system to reduce food intake and change hormone levels, rather than just focusing on weight loss. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment for Type 2 Diabetes?

Research shows that both Roux-en-Y gastric bypass (a type of weight-loss surgery) and a very low-calorie diet can improve blood sugar control and insulin function in people with type 2 diabetes, even before significant weight loss occurs. This suggests that both treatments can be effective in managing diabetes. ^{3 6 8 10 11}

Who Is on the Research Team?

Samuel Klein, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for obese individuals with or without Type 2 Diabetes, having a BMI between 34-55 kg/m². They must not use tobacco, be pregnant/breastfeeding, have had previous intestinal surgery, significant organ dysfunction (other than diabetes), or take meds affecting metabolism. Exercise should be less than 90 minutes per week.

Inclusion Criteria

I have Type 2 Diabetes.

Your Body Mass Index (BMI) is between 34 and 55.

I am scheduled for RYGB surgery, have a BMI of 34-55, and have Type 2 Diabetes.

Exclusion Criteria

I don't smoke, haven't had intestinal surgery, am not pregnant or breastfeeding, don't have major organ issues, don't take meds affecting metabolism, and exercise less than 90 minutes a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Roux-en-Y gastric bypass surgery or participate in a low-calorie diet intervention to achieve targeted weight loss

6 months

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for changes in insulin sensitivity, beta-cell function, and metabolic profiles after weight loss

6 months

Follow-up assessments before and after weight loss

What Are the Treatments Tested in This Trial?

Interventions

• Low-calorie diet
• Roux-en-Y Gastric Bypass

Trial Overview The study compares the effects of Roux-en-Y Gastric bypass (RYGB) surgery and a low-calorie diet on weight loss and metabolic health in obese patients. It looks at how each method affects insulin sensitivity in the liver and muscles, beta-cell function, and overall metabolic balance over a day.

How Is the Trial Designed?

Group I: Roux-en-Y gastric bypass (RYGB) Experimental Treatment 1 Intervention

Subjects in this group are scheduled to undergo roux-en-Y gastric bypass surgery to obtain approximately 16-18% (with a range of 16-25%) weight loss.

Group II: Low-calorie diet Active Control 1 Intervention

Subjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 213 type 2 diabetes patients with a BMI of 25 to 32.5 kg/m2, Roux-en-Y gastric bypass (RYGB) was found to be more effective than medical treatment in achieving significant metabolic improvements, with 23.9% of RYGB patients meeting the triple endpoint compared to only 7.0% in the medical group.

However, RYGB was associated with a higher rate of complications (36 vs. 22), highlighting the need to weigh the benefits of improved metabolic outcomes against the risks of surgical complications when considering treatment options for patients with lower BMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes of Roux-en-Y gastric bypass vs medical treatment in type 2 diabetes with a body mass index lower than 32.5 kg/m2: a multicenter propensity score-matched analysis. Ling, J., Tang, H., Meng, H., et al.[2022]

Citations

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

Gastric volume reduction is essential for the remission of type 2 diabetes mellitus after bariatric surgery in nonobese rats. [2017]

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

Roux-en-Y gastric bypass for nonobese patients with uncontrolled type 2 diabetes: a long-term evaluation. [2020]

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

Diabetes remission and reduced cardiovascular risk after gastric bypass in Asian Indians with body mass index [2022]

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

Very low-calorie diet mimics the early beneficial effect of Roux-en-Y gastric bypass on insulin sensitivity and β-cell Function in type 2 diabetic patients. [2022]

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

A meta-analysis of short-term outcomes of patients with type 2 diabetes mellitus and BMI ≤ 35 kg/m2 undergoing Roux-en-Y gastric bypass. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Two-year outcomes of Roux-en-Y gastric bypass vs medical treatment in type 2 diabetes with a body mass index lower than 32.5 kg/m2: a multicenter propensity score-matched analysis. [2022]

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

Gastric bypass in the treatment of type 2 diabetes in patients with a BMI of 30 to 35 kg/m2. [2021]

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

Risk of Malnutrition, Trace Metal, and Vitamin Deficiency Post Roux-en-Y Gastric Bypass--a Prospective Study of 20 Patients with BMI [2021]

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

Long-term outcomes of Roux-en-Y gastric bypass versus medical therapy for patients with type 2 diabetes: a meta-analysis of randomized controlled trials. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Perioperative glycaemic control in insulin-treated type 2 diabetes patients undergoing gastric bypass surgery. [2014]

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

Pancreatic islet isolation after gastric bypass in a rat model: technique and initial results for a promising research tool. [2022]