Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment
25 Years
65 Years
Both
Diabetes Mellitus, Type 2, Obesity
Trial Information
Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Outcome Description:
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.
Outcome Time Frame:
April 2011 - January 2012
Safety Issue:
No
Principal Investigator
David E Cummings, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Washington
Authority:
United States: Institutional Review Board
Study ID:
194279
NCT ID:
NCT01295229
Start Date:
May 2011
Completion Date:
August 2013
Related Keywords:
- Diabetes Mellitus, Type 2
- Obesity
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Obesity
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Group Health Research Institute | Seattle, Washington 98101 |
