Surgical vs. Lifestyle Interventions for Type 2 Diabetes

(TRIABETES Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: Anti-diabetic medications

Disqualifiers: Prior bariatric surgery, Poor health, Addiction, Smoking, Pregnancy, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

69 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.

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, since the study involves surgical and lifestyle interventions for Type 2 diabetes, it's best to discuss your medications with the study team.

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

Roux-en-Y gastric bypass surgery has been shown to reduce the risk of major heart-related events and lower mortality in patients with obesity, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the treatment of surgical and lifestyle interventions for type 2 diabetes differ from other treatments?

Surgical interventions like Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding are unique because they involve altering the digestive system to help with weight loss and improve blood sugar control, often leading to remission of type 2 diabetes. These surgeries can be more effective than lifestyle changes or medications alone, especially in patients with obesity, by providing long-term metabolic control and reducing cardiovascular risks. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Laparoscopic Adjustable Gastric Banding, Lifestyle Weight Loss Intervention, Roux-en-Y Gastric Bypass Surgery for Type 2 Diabetes?

Research shows that Roux-en-Y gastric bypass surgery can lead to high remission rates of type 2 diabetes, with some studies reporting up to 66.7% remission. Laparoscopic adjustable gastric banding has been associated with a lower remission rate of 28.6%, but both surgical options generally outperform lifestyle interventions alone in managing type 2 diabetes. ^{2 6 8 11 12}

Who Is on the Research Team?

Anita Courcoulas

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 25-55 with Type 2 diabetes and mild to moderate obesity (BMI between 30-40 kg/m2). Candidates should be willing to undergo surgery or a lifestyle intervention, have difficulty controlling diabetes medically, and not smoke. Exclusions include prior bariatric surgery, poor health, substance addiction, current pregnancy or research participation.

Inclusion Criteria

I am willing to undergo surgery if randomly selected.

I have a BMI between 35 and 40 and either have high fasting blood sugar or am on diabetes medication.

I have type 2 diabetes that's hard to manage with medication and my BMI is between 30 to 35.

Exclusion Criteria

You have difficulty thinking clearly or understanding things.

You have a problem with using drugs or alcohol.

Current participation in any other research study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Laparoscopic Roux-en-Y Gastric Bypass, Laparoscopic Adjustable Gastric Banding, or an intensive lifestyle intervention to induce weight loss

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of diabetes resolution, glucose control, and physical activity

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Laparoscopic Adjustable Gastric Banding
• Lifestyle Weight Loss Intervention
• Roux-en-Y Gastric Bypass Surgery

Trial Overview The study compares the effectiveness of two bariatric surgeries—Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding—with an intensive lifestyle weight loss program in improving Type 2 diabetes in moderately obese patients.

How Is the Trial Designed?

Group I: Roux-en-Y Gastric Bypass Surgery Experimental Treatment 1 Intervention

Roux-en-Y Gastric Bypass Surgery

Group II: Lifestyle/Behavioral Weight Loss Experimental Treatment 1 Intervention

Lifestyle Weight Loss Intervention

Group III: Laparoscopic Adjustable Gastric Banding Experimental Treatment 1 Intervention

Laparoscopic Adjustable Gastric Banding

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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 1,009 patients with class II and III obesity, those who underwent Roux-en-Y gastric bypass (RYGB) surgery within one year had a significantly lower risk of major adverse cardiovascular events (MACE) compared to those who were medically managed, with an adjusted hazard ratio of 0.62.

RYGB surgery also resulted in lower mortality rates (adjusted HR of 0.51), indicating its potential effectiveness in improving long-term health outcomes for obese patients, although it did not significantly reduce the occurrence of new-onset atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long-Term Impact of Bariatric Surgery on Development of Atrial Fibrillation and Cardiovascular Events in Obese Patients: An Historical Cohort Study. Yuan, H., Medina-Inojosa, JR., Lopez-Jimenez, F., et al.[2021]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial. [2018]

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

Laparoscopic gastric banding prevents type 2 diabetes and arterial hypertension and induces their remission in morbid obesity: a 4-year case-controlled study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Obesity, bariatric surgery and type 2 diabetes--a systematic review. [2018]

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

Remission of type 2 diabetes: is bariatric surgery ready for prime time? [2018]

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

Solutions in weight control: lessons from gastric surgery. [2023]

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

Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. [2018]

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

Patient factors associated with undergoing laparoscopic adjustable gastric banding vs Roux-en-Y gastric bypass for weight loss. [2021]

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

Band versus bypass: influence of an educational seminar and surgeon visit on patient preference. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Long-Term Impact of Bariatric Surgery on Development of Atrial Fibrillation and Cardiovascular Events in Obese Patients: An Historical Cohort Study. [2021]

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

Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial. [2020]

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

Weight loss and changes in use of antidiabetic medication in obese type 2 diabetics after laparoscopic gastric banding. [2010]

12. China pubmed.ncbi.nlm.nih.gov

Metabolic surgery: gastric bypass for the treatment of type 2 diabetes mellitus. [2020]