Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes (CROSSROADS)
|Diabetes Mellitus, Type 2 Obesity||Procedure: laparoscopic Roux-en-Y gastric bypass (RYGB) procedure Behavioral: Lifestyle Intervention|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment|
- Feasibility [ Time Frame: April 2011 - January 2012 ]Explore the feasibility of a set of novel methods to create an appropriate randomization cohort of patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30-40 kg/m2 who are willing to be randomized into either roux-en-Y gastric bypass (RYGB) surgery or an intensive medical/lifestyle intervention. This will be assessed by comparing the number of people recruited to the number randomized and subsequently enrolled in the study.
- Efficacy and Mechanisms [ Time Frame: April 2011-April 2013 ]Participants will complete research visits at Baseline, 6-month and 12-month. Both intervention groups (surgery and lifestyle) will complete the same physical assessments to compare success of the intervention. Physical measures include a fasting blood draw, DEXA scan, exercise treadmill test, anthropometric measures and vitals. Additionally, a subset of participants will be assessed for changes in their immune system before and after the intervention. Measures include an adiopose tissue biopsy and an Oral Glucose Tolerance Test.
|Study Start Date:||May 2011|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Lifestyle Intervention||
Behavioral: Lifestyle Intervention
The lifestyle intervention includes behavior-modification skills counseling combined with training in diet and exercise change. The focus of the exercise intervention is a gradual increase in brisk walking or other activities of similar moderate aerobic intensity. The exercise prescription will consist of at least 45 minutes of exercise, 5 days per week for 12 months. The diet intervention will be conducted by a research dietician with training in behavior modification, with supervision by Dr. Foster-Schubert. In week 1 the dietician will meet for a 60-minute individual session with participants at the FHCRC Prevention Center. Over the next 23 weeks the dietician will conduct one 30-minute group session per week.
Other Name: Diet and Exercise Program
|Active Comparator: Surgery||
Procedure: laparoscopic Roux-en-Y gastric bypass (RYGB) procedure
The laparoscopic Roux-en-Y gastric bypass (RYGB) procedure is the most commonly performed bariatric procedure in the United States. Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons, using a 90-cm alimentary limb, 50-cm biliopancreatic limb, antecolic/antegastric approach, and totally stapled technique.
The overall goal of the research study is to demonstrate our capacity to identify, recruit, randomize, and track outcomes for 40 adult Group Health members identified as having T2DM and a BMI between 30-40 kg/m2.
Our cohort recruitment strategy will utilize the GH administrative and clinical databases to identify patients with T2DM and a BMI of 30-40 kg/m2. Sufficient numbers (N=4,000) of these individuals will be mailed and surveyed to identify the small minority without strong preferences regarding medical vs. surgical diabetes/obesity treatment. This subset will be invited to become better informed about both strategies using a novel, standardized patient decision aid for shared decision making (SDM) related to bariatric surgery: a high-quality educational video that provides balanced and frequently updated information about the risks and benefits of surgical and non-surgical care. After viewing SDM tool, potential subjects' "willingness to randomize" will be assessed, and a subset of willing patients will actually undergo randomization to either RYGB or a state-of-the-art intensive but reproducible medical/lifestyle intervention.
Forty patients will be randomized to either RYGB or an intensive medical/lifestyle intervention. Twenty members will be randomly assigned to intensive behavioral/medical treatment, and twenty will be randomly assigned to receive gastric bypass surgery. In the non-surgical group, the investigators will study the feasibility and resources needed to deploy a state-of-the-art intensive behavioral intervention to promote weight loss, which includes dietary and exercise components. It will be coupled with diabetes pharmacotherapy treatment consistent with Group Health Clinical Practice Guidelines (http://incontext.ghc.org/clinical/clin_topics/diabetes2/dm2_poc.html).
Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons. The operation and post-operative care will be performed at GH by Dr. Steven Bock, Dr. Jeffery Lander, and their clinical staff, including a team of nutritionists and a Registered Nurse Case Manager who coordinates the care of patients in the GH Bariatric Surgery Program. Surgical patients will also undergo a standardized 8-week pre-operative and 10-month post-operative behavioral treatment regimen with the GH Bariatric Surgery Program.
Participants will have follow-up research visits at 3, 6, 9, and 12 months after randomization, where they will have the following measurements: standardized physically exam by Dr. Foster-Schubert; weight, waist and hip circumferences; systolic and diastolic blood pressure; resting 1-minute pulse; and fasting (12-hour) blood (50 ml) collection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295229
|United States, Washington|
|Group Health Research Institute|
|Seattle, Washington, United States, 98101|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||David E Cummings, MD||University of Washington|
|Principal Investigator:||David R Flum, MD, MPH||University of Washington|