Clinical trial NCT01040468: Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)
Official title: Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Bariatric Surgery
Roux-en-Y Gastric Bypass
Gastric Banding
Obesity
Weight loss
Insulin sensitivity
GLP-1
Meal Challenge
Euglycemic Clamp
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-12-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study will investigate the safety and effectiveness of weight loss surgery for overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or an intensive lifestyle modification. Participants will be closely followed for one year to compare the effects of these treatments on diabetes remission.


Eligibility criteria: Inclusion Criteria:

* Ages 18 to 65 years old.
* 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:

* Diagnosis of type 1 diabetes, diagnosis of maturity-onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA) (all of which are associated with ß-cell destruction), daily insulin requirements \> 100 units, and poor preoperative glycemic control, as indicated by a HbA1c \> 6.5 - ≤ 8.5 or HbA1c \> 8.6 - \< 9.5 (individuals with this HbA1c value will require medical clearance and approval from the study physician).
* 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.

Primary outcomes:
measure: The primary objective of this study is to compare the rates of diabetes remission over one year.
timeFrame: One year
Secondary outcomes:
measure: Secondary objectives of this study are to determine the effects of the three treatment conditions on insulin sensitivity, endogenous glucose production, postprandial insulin release, and levels of gut hormones (including GLP-1).
timeFrame: One year
measure: To compare other benefits (e.g., improvements in quality of life, dietary intake, and physical activity), as well as risks (e.g., hypoglycemia, cholecystitis, early and late surgical complications), of the three interventions.
timeFrame: One year
measure: To examine the attitudes that patients, health care professionals, and insurance providers have toward the use of bariatric surgery to treat type 2 diabetes.
timeFrame: One year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David B Sarwer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Thomas A Wadden, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania Department of Surgery
name: Noel Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References: