Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Obesity

In brief

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.

Key facts

Study ID

NCT01295229

Run by

University of Washington

People needed

43

Starts

2011-05-01

Expected to finish

2015-06-01

Last updated by the study team

2016-03-31

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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):
• 1+ 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
• Any prior liver, heart, intestinal, and/or lung transplant

Where it is running

• Group Health Research Institute — Seattle, Washington, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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