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Procedure
Surgical vs. Lifestyle Interventions for Type 2 Diabetes (TRIABETES Trial)
N/A
Waitlist Available
Led By Anita P Courcoulas, MD, MPH
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willingness to be randomized to a surgical intervention
For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented fasting blood glucose > 126 mg/dl OR treatment with an anti-diabetic medication
Must not have
Unable to communicate with study staff
Unable to exercise (walk a city block or a flight of stairs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is being done to compare the effectiveness of two types of bariatric surgery against an intensive lifestyle intervention in promoting weight loss and improvements in Type 2 diabetes in moderately obese patients.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from the surgical interventions may include nutritional deficiencies, gastrointestinal issues like nausea or vomiting, surgical complications such as infections or bleeding. The lifestyle intervention could lead to muscle strains or stress injuries from increased physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to undergo surgery if randomly selected.
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I have a BMI between 35 and 40 and either have high fasting blood sugar or am on diabetes medication.
Select...
I am between 25 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot communicate with the study team.
Select...
I cannot walk a city block or climb a flight of stairs.
Select...
I have portal hypertension or cirrhosis.
Select...
I have had weight loss or upper digestive tract surgery before.
Select...
I have Type 1 Diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Group I: Roux-en-Y Gastric Bypass SurgeryExperimental Treatment1 Intervention
Roux-en-Y Gastric Bypass Surgery
Group II: Lifestyle/Behavioral Weight LossExperimental Treatment1 Intervention
Lifestyle Weight Loss Intervention
Group III: Laparoscopic Adjustable Gastric BandingExperimental Treatment1 Intervention
Laparoscopic Adjustable Gastric Banding
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roux-en-Y Gastric Bypass Surgery
2014
N/A
~30
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,934 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,442 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,822 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have difficulty thinking clearly or understanding things.You have a problem with using drugs or alcohol.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.I cannot communicate with the study team.My BMI is between 30 and 40, indicating mild to moderate obesity.I cannot walk a city block or climb a flight of stairs.You are not in good overall health.You are currently a smoker.I am between 25 and 55 years old.I have portal hypertension or cirrhosis.I have had weight loss or upper digestive tract surgery before.I have Type 1 Diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Laparoscopic Adjustable Gastric Banding
- Group 2: Roux-en-Y Gastric Bypass Surgery
- Group 3: Lifestyle/Behavioral Weight Loss
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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