The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 25 - 55 |
| Updated: | 4/17/2018 |
| Start Date: | September 2009 |
| End Date: | February 2019 |
Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes (Triabetes) - Alliance of Randomized Trials of Medicine vs. Metabolic Surgery in Type 2 Diabetes ARMMST2D)
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.
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.
The Specific Aims of the first phase of the study are as follows:
Aim 1. To determine the feasibility of performing a randomized trial comparing two major
types of bariatric surgery, Laparoscopic Roux en Y Gastric Bypass (RNY) and Laparoscopic
Adjustable Gastric Banding (GB) versus a lifestyle weight loss intervention (LWLI) induced by
diet and increased physical activity in moderately obese patients (Class I and II obesity)
with T2DM. We hypothesize that: 1) A randomized design with both surgical and non-surgical
arms will be both feasible and acceptable to participants and to providers 2) There will be
no difference in retention rates between the LWLI and surgical arms (RNY, GB) of the study
and it will provide estimates of overall retention for future studies.
Aim 2. To obtain preliminary information regarding the effectiveness of two dominant
bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss
with diet and increased physical activity. We hypothesize that: 1) RNY will be superior to GB
and LWLI in weight lost in 12 months.
Aim 3. To explore the feasibility, methods for, and implementation of a range of early
outcome measures including; resolution of diabetes, glucose control, medication usage,
insulin resistance, beta cell function, body composition, objective measures of physical
activity, and several psychosocial measures. We hypothesize that: 1) Participants will be
willing to undergo a range of early outcome testing measures to assess metabolic change, body
composition alterations, objective physical activity, and psychosocial factors. 2) Measures
of T2DM improvement including an intravenous glucose tolerance test (IVGTT) will be feasible
in a subset of participants in each study arm and RNY will be superior to both GB and LWLI
for the clinical and metabolic improvement of T2DM. 3) The LWLI group will show improvements
in physical activity compared to RNY and GB.
Aim 1. To determine the feasibility of performing a randomized trial comparing two major
types of bariatric surgery, Laparoscopic Roux en Y Gastric Bypass (RNY) and Laparoscopic
Adjustable Gastric Banding (GB) versus a lifestyle weight loss intervention (LWLI) induced by
diet and increased physical activity in moderately obese patients (Class I and II obesity)
with T2DM. We hypothesize that: 1) A randomized design with both surgical and non-surgical
arms will be both feasible and acceptable to participants and to providers 2) There will be
no difference in retention rates between the LWLI and surgical arms (RNY, GB) of the study
and it will provide estimates of overall retention for future studies.
Aim 2. To obtain preliminary information regarding the effectiveness of two dominant
bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss
with diet and increased physical activity. We hypothesize that: 1) RNY will be superior to GB
and LWLI in weight lost in 12 months.
Aim 3. To explore the feasibility, methods for, and implementation of a range of early
outcome measures including; resolution of diabetes, glucose control, medication usage,
insulin resistance, beta cell function, body composition, objective measures of physical
activity, and several psychosocial measures. We hypothesize that: 1) Participants will be
willing to undergo a range of early outcome testing measures to assess metabolic change, body
composition alterations, objective physical activity, and psychosocial factors. 2) Measures
of T2DM improvement including an intravenous glucose tolerance test (IVGTT) will be feasible
in a subset of participants in each study arm and RNY will be superior to both GB and LWLI
for the clinical and metabolic improvement of T2DM. 3) The LWLI group will show improvements
in physical activity compared to RNY and GB.
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)
We found this trial at
1
site
300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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