Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)
NCT ID: NCT01040468
Last Updated: 2016-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
7 participants
INTERVENTIONAL
2009-09-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Roux-en-Y Gastric Bypass surgery
Surgical intervention for weight loss
Roux-en-Y Gastric Bypass surgery
Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
Laparoscopic Adjustable Gastric Banding surgery
Surgical intervention for weight loss
Laparoscopic Adjustable Gastric Banding surgery
Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
Intensive Lifestyle Modification
Lifestyle intervention for weight loss
Intensive Lifestyle Modification
Intensive lifestyle modification program for weight loss. Participants randomized to this condition will receive an weekly individual treatment of 30 minutes for the first 6 months and every-other-week sessions from months 7 to 12. Treatment will be provided by a behavioral psychologist or registered dietitian following a structured curriculum used in our prior studies. During the first 4 months, participants will be prescribed a 1000-1200 kcal/d diet that provides four daily servings of meal replacement products (liquid shakes, cereals, meal bars, etc), combined with an evening dinner entree. Each serving of the meal replacement (HMR 170; Boston, MA) will provide 170 calories, with 16 g of protein, 22 g of carbohydrate, and 2 g of fat. Dinner entrees (containing at least 20 g of protein and approximately 220-260 kcal) will be consumed with a garden salad and a serving of fruit (and other vegetables allowed ad libitum throughout the day).
Interventions
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Roux-en-Y Gastric Bypass surgery
Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
Laparoscopic Adjustable Gastric Banding surgery
Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
Intensive Lifestyle Modification
Intensive lifestyle modification program for weight loss. Participants randomized to this condition will receive an weekly individual treatment of 30 minutes for the first 6 months and every-other-week sessions from months 7 to 12. Treatment will be provided by a behavioral psychologist or registered dietitian following a structured curriculum used in our prior studies. During the first 4 months, participants will be prescribed a 1000-1200 kcal/d diet that provides four daily servings of meal replacement products (liquid shakes, cereals, meal bars, etc), combined with an evening dinner entree. Each serving of the meal replacement (HMR 170; Boston, MA) will provide 170 calories, with 16 g of protein, 22 g of carbohydrate, and 2 g of fat. Dinner entrees (containing at least 20 g of protein and approximately 220-260 kcal) will be consumed with a garden salad and a serving of fruit (and other vegetables allowed ad libitum throughout the day).
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 2 diabetes.
* Individuals with a BMI of 30-40 kg/m2
* Approval for bariatric surgery (as confirmed by medical evaluation)
* Insurance coverage for bariatric surgery
* Willingness to change diet, physical activity and weight.
* Ability to communicate with the investigator and be legally competent, provide written informed consent.
Exclusion Criteria
* Children and adolescents are not eligible to participate in the study.
* Pregnant women (or those who intend to become pregnant during the study period) and women who are currently breastfeeding are not eligible to participate.
* Use of medications known to significantly increase body weight, such as chronic systemic steroids or certain psychiatric medications (e.g., lithium tricyclic antidepressants and anti-psychotic agents).
* Non-ambulatory individuals, defined as those who are unable to walk at least one city block without a cane or walker.
* Any major illnesses that the surgical team believes present too great a risk for surgery. These include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.
* Evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that is uncontrolled, poorly controlled, or, in the opinion of the Investigators, significantly interferes with daily living and functioning.
* Any current (past 12 months) substance abuse or dependence disorder.
* Participants with moderate anemia (Hgb \< 12 mg/dl for men and Hgb \< 11 mg/dl for women)
* Conditions that may falsely elevate or decrease HbA1c values, including hemolytic or iron-deficiency anemia, hemoglobinopathies, and uremia.
* Abnormal laboratory tests which are clinically significant per the investigator.
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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David B Sarwer, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Thomas A Wadden, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Noel Williams, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Department of Surgery
Locations
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University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Center for Weight and Eating Disorders website
Bariatric Surgery Program at Penn website
Other Identifiers
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809984
Identifier Type: -
Identifier Source: org_study_id
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