The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments fo… (NCT01047735) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
United States69 participantsStarted 2009-09-01
Plain-language summary
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.
Who can participate
Age range
25 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 25 to 55 years
* Mild to moderate obesity with a BMI between 30 and 40 kg/m2
* 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
* For potential subjects with BMI 30 to 35 kg/m2: T2DM that is difficult to control medically and is recommended for the study by the subject's endocrinologist AND treatment with an anti-diabetic medication
* Willingness to be randomized to a surgical intervention
Exclusion Criteria:
* Prior bariatric or foregut surgery
* Poor overall general health
* Impaired mental status
* Drug and/or alcohol addiction
* Current smoking
* Pregnant or plans to become pregnant
* Type 1 Diabetes Mellitus
* Portal hypertension and/or Cirrhosis
* Failed study-related nutrition or psychological assessment
* Current participation in any other research study
* Inability to provide informed consent
* Unlikely to comply with study protocol
* Unable to communicate with study staff
* Unable to exercise (walk a city block or a flight of stairs)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two types of bariatric surgery against a lifestyle program involving diet and exercise for type 2 diabetes — given my specific situation, which of those three arms would my doctor think is the most appropriate path for me to discuss?
2Since this study is listed as 'active not recruiting,' does that mean I can no longer join, and if so, are there similar trials or published results from this one that my doctor could use to guide my treatment decisions?
3The trial is focused on moderately obese patients with type 2 diabetes — how does my current weight and diabetes control compare to the kinds of patients enrolled, and would that affect whether bariatric surgery is even worth considering in my case?
4Because this is a Phase NA feasibility study, it was primarily designed to test whether this kind of trial could be run at all, rather than to prove which treatment works best — so what does my doctor think the actual evidence says so far about surgery versus lifestyle intervention for managing my type 2 diabetes?
5If bariatric surgery is one of the options being studied here, what are the realistic short- and long-term risks I should understand before my doctor and I could even begin weighing it against continuing with a lifestyle or medication-based approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of performing a randomized trial comparing two major types of bariatric surgery versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients with T2DM.