Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes

NCT01295229 | Completed DMC

• 2 other identifiers: 1942791R01DK089528-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through mechanisms beyond just weight loss, but its role in diabetes management and the nature of its weight-independent anti-diabetes effects are not well established because of a paucity of appropriate randomized trials, the execution of which is hindered by numerous obstacles. The investigators therefore propose a feasibility study 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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Outcome Measures

Primary Outcomes (1)

• Feasibility

  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.

  April 2011 - January 2012

Secondary Outcomes (1)

• Efficacy and Mechanisms

  April 2011-April 2013

Study Arms (2)

Lifestyle Intervention

ACTIVE COMPARATOR

Behavioral: Lifestyle Intervention

Surgery

ACTIVE COMPARATOR

Procedure: laparoscopic Roux-en-Y gastric bypass (RYGB) procedure

Interventions

laparoscopic Roux-en-Y gastric bypass (RYGB) procedure 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.

Also known as: weight loss surgery, bariatric surgery

Surgery

Lifestyle Intervention BEHAVIORAL

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.

Also known as: Diet and Exercise Program

Lifestyle Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently enrolled at Group Health
• currently enrolled in a GH insurance product that provides coverage for laparoscopic gastric bypass (e.g., Medicare, PEBB, or has GH bariatric coverage rider)
• age on January 1, 2011 will be between 25 and 65 years
• Diabetes: must meet one or more of the following criteria during the past two years (10/1/08 - 9/30/10):
• + fills for a diabetes-specific medication (oral or insulin)
• Hemoglobin A1c ≥7.0% on one or more occasions
• Fasting Blood glucose ≥126 mg/dL on two or more occasions \[separate days\]
• Random glucose ≥200 mg/dl on two or more occasions \[separate days\]
• One fasting blood glucose ≥126 mg/dL plus one random glucose ≥200 mg/dl \[must occur on separate days\]
• One or more inpatient (primary or secondary hospital discharge) code related to diabetes. See list below.
• Two or more outpatient ICD-9 codes related to diabetes (ambulatory visits (AV) only - not telephone, email, emergency department, lab, radiology, or other (IS, OE) encounter types) \[Two visits must occur on separate days\]
• Obesity: All patients must have a body mass index \[BMI\] between 30 and \<40kg/m2; weight measurement must be within the past two years (10/1/08 - 9/30/10)

You may not qualify if:

• Pregnancy within the past one year (10/1/09 - 9/30/10)
• Excluded if the following conditions are recorded within the past two years (10/1/08 - 9/30/10):
• malignant tumor
• ascites
• peritoneal effusion
• cirrhosis
• schizophrenia
• schizoaffective disorder
• bipolar disorder
• dementia
• HIV
• inflammatory bowel disease
• dialysis
• Exclude if occurred between 1/1/95 - 9/30/10:
• Any prior bariatric or major gastrointestinal operation

Sponsors & Collaborators

• University of Washington: lead
• Kaiser Permanente: collaborator
• Fred Hutchinson Cancer Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• Banerjee S, Garrison LP Jr, Flum DR, Arterburn DE. Cost and Health Care Utilization Implications of Bariatric Surgery Versus Intensive Lifestyle and Medical Intervention for Type 2 Diabetes. Obesity (Silver Spring). 2017 Sep;25(9):1499-1508. doi: 10.1002/oby.21927. Epub 2017 Jul 19.

  PMID: 28722299 DERIVED

• Cummings DE, Arterburn DE, Westbrook EO, Kuzma JN, Stewart SD, Chan CP, Bock SN, Landers JT, Kratz M, Foster-Schubert KE, Flum DR. Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial. Diabetologia. 2016 May;59(5):945-53. doi: 10.1007/s00125-016-3903-x. Epub 2016 Mar 17.

  PMID: 26983924 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Bariatric Surgery; Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• David E Cummings, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• David R Flum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 14, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

US (2)