Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

Type 2 Diabetes Clinical Trial

— SOLID  

Official title:

Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040468
• Other study ID #: 809984
• Secondary ID: 1RC1DK086132
• Status: Completed
• Phase: Phase 3
• First received: December 24, 2009
• Last updated: August 17, 2016
• Start date: September 2009
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Procedure:
• 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.

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	University of Pennsylvania Center for Weight and Eating Disorders	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to compare the rates of diabetes remission over one year.		One year	No
Secondary	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).		One year	No
Secondary	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.		One year	Yes
Secondary	To examine the attitudes that patients, health care professionals, and insurance providers have toward the use of bariatric surgery to treat type 2 diabetes.		One year	No

External Links

•   Bariatric Surgery Program at Penn website
•   Center for Weight and Eating Disorders website