Clinical trial NCT01295229: Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes
Official title: Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: Fred Hutchinson Cancer Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-02-14
Enrollment: 43
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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):

  1. 1+ fills for a diabetes-specific medication (oral or insulin)
  2. Hemoglobin A1c ≥7.0% on one or more occasions
  3. Fasting Blood glucose ≥126 mg/dL on two or more occasions \[separate days\]
  4. Random glucose ≥200 mg/dl on two or more occasions \[separate days\]
  5. One fasting blood glucose ≥126 mg/dL plus one random glucose ≥200 mg/dl \[must occur on separate days\]
  6. One or more inpatient (primary or secondary hospital discharge) code related to diabetes. See list below.
  7. 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)

Exclusion Criteria:

* 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):

  1. malignant tumor
  2. ascites
  3. peritoneal effusion
  4. cirrhosis
  5. schizophrenia
  6. schizoaffective disorder
  7. bipolar disorder
  8. dementia
  9. HIV
  10. inflammatory bowel disease
  11. dialysis
* Exclude if occurred between 1/1/95 - 9/30/10:

  1. Any prior bariatric or major gastrointestinal operation
  2. Any prior liver, heart, intestinal, and/or lung transplant

Primary outcomes:
measure: Feasibility
timeFrame: April 2011 - January 2012
Secondary outcomes:
measure: Efficacy and Mechanisms
timeFrame: April 2011-April 2013
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: University of Washington
name: David E Cummings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: David R Flum, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.