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 |
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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
Click here to add this to my saved trials