Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes



Status:Completed
Conditions:Obesity Weight Loss, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:25 - 65
Updated:4/21/2016
Start Date:May 2011
End Date:June 2015

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Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment

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.

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
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1100 Fairview Avenue North
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(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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