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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of weight-loss surgeries to lifestyle changes in improving Type 2 diabetes in moderately obese individuals. The researchers aim to determine if surgical interventions like Laparoscopic Roux-en-Y Gastric Bypass or Laparoscopic Adjustable Gastric Banding are more effective than diet and exercise alone. Suitable candidates for this trial have a Type 2 diabetes diagnosis, a BMI of 30-40 (indicating they are roughly 65-95 pounds overweight), and difficulty controlling their diabetes with medication. As an unphased study, this trial provides a unique opportunity to explore innovative treatments for diabetes management.

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

In a previous study, Laparoscopic Adjustable Gastric Banding (LAGB) resulted in about 22% of patients experiencing minor complications, while 39% faced major issues like band erosion. Despite these risks, the procedure often led to significant weight loss and improvements in Type 2 diabetes. Research indicates that patients with diabetes may face higher surgery risks, especially if their condition isn't well controlled.

For Roux-en-Y Gastric Bypass (RYGB) surgery, studies have shown it results in more weight loss and better diabetes remission compared to other procedures. However, this surgery also has higher complication rates than some other options.

Lifestyle changes, such as improving diet and exercise, have been shown in the Diabetes Prevention Program to reduce the risk of developing diabetes by 58% over three years. However, these changes often result in less than 5% weight loss and might not significantly lower heart disease risks in those with Type 2 diabetes.

Each option has benefits, but it's important to weigh them against potential risks and discuss them with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Type 2 Diabetes because they offer diverse approaches beyond traditional medication and lifestyle changes. Laparoscopic Adjustable Gastric Banding is distinctive due to its minimally invasive nature, which involves placing a band around the stomach to limit food intake and promote weight loss. Roux-en-Y Gastric Bypass Surgery is notable for its ability to significantly alter the digestive system, leading to substantial and rapid weight loss, which can improve or even resolve diabetes. The Lifestyle Weight Loss Intervention focuses on sustainable behavioral changes, emphasizing diet and exercise, which can empower individuals to manage their diabetes through natural means. Each approach presents unique benefits, potentially providing more personalized and effective treatment options for managing Type 2 Diabetes.

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

This trial will compare Laparoscopic Adjustable Gastric Banding, Roux-en-Y Gastric Bypass Surgery, and a Lifestyle Weight Loss Intervention for their effects on type 2 diabetes. Research has shown that both Laparoscopic Adjustable Gastric Banding and Roux-en-Y Gastric Bypass Surgery can greatly improve type 2 diabetes. Studies found that about 80% of patients undergoing Laparoscopic Adjustable Gastric Banding experienced improvement or remission of their diabetes. Roux-en-Y Gastric Bypass Surgery has been even more impressive, with some studies showing diabetes remission lasting up to 15 years. In contrast, significant lifestyle changes, such as improving diet and exercise, can reduce the risk of developing diabetes by 58% if maintained. Each option shows promise, but surgery typically offers longer-lasting results for diabetes remission. ^{3 6 7 8 9}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20627708/

Five-year outcomes of patients with type 2 diabetes who ... The combined improvement/remission rate was 80% (64 of 80 patients). Conclusion: Our data have demonstrated that laparoscopic adjustable gastric banding results ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728910000833

Five-year outcomes of patients with type 2 diabetes who ... Our data have demonstrated that LAGB results in a substantial positive effect on diabetes in morbidly obese patients, 5 years after surgery, with a significant ...

3. nature.com nature.com/articles/s41366-023-01368-4

Laparoscopic adjustable gastric banding with liraglutide in ... Our study showed no differences in HbA1c or weight at 6 months between the two arms. However given the treatment duration of only 6 months, ...

4. diabetesjournals.org diabetesjournals.org/care/article/25/2/358/23348/Health-Outcomes-of-Severely-Obese-Type-2-Diabetic

Health Outcomes of Severely Obese Type 2 Diabetic Subjects ... Remission of diabetes occurred in 32 patients (64%), and major improvement of glucose control occurred in 13 patients (26%); glucose metabolism ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2019/03010/meta_analysis_of_the_effectiveness_of_laparoscopic.66.aspx

Meta-analysis of the effectiveness of laparoscopic... LSG is a more effective procedure than LAGB for morbidly obese patients, contributing to a higher %EWL and greater improvement in T2DM. 1 Introduction. World ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21422330/

Long-term outcomes of laparoscopic adjustable gastric ... Based on a follow-up of 54.3% of patients, LAGB appears to result in a mean excess weight loss of 42.8% after 12 years or longer. Of 78 patients, 47 (60.3%) ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15603648/

Effect of Lap-Band-induced weight loss on type 2 diabetes ... Dramatic improvement in - and frequent resolution of - diabetes and hypertension have been observed as a result of weight loss after Lap-Band surgery.

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/1107072

Long-term Outcomes of Laparoscopic Adjustable Gastric ... Twenty-two percent of patients experienced minor complications, and 39% experienced major complications (28% experienced band erosion). Seventeen percent of ...

9. bariatrictimes.com bariatrictimes.com/laparoscopic-adjustable-gastric-banding-and-type-2-diabetes/

Laparoscopic Adjustable Gastric Banding and Type 2 ... Patients with diabetes in general may have a higher chance to develop complications following any surgical procedure, especially patients with no optimal ...