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Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID) (SOLID)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Roux-en-Y Gastric Bypass surgery

Laparoscopic Adjustable Gastric Banding surgery

Intensive Lifestyle Modification

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Bariatric Surgery, Roux-en-Y Gastric Bypass, Gastric Banding, Obesity, Weight loss, Insulin sensitivity, GLP-1, Meal Challenge, Euglycemic Clamp

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Pennsylvania Center for Weight and Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Roux-en-Y Gastric Bypass surgery

Laparoscopic Adjustable Gastric Banding surgery

Intensive Lifestyle Modification

Arm Description

Surgical intervention for weight loss

Lifestyle intervention for weight loss

Outcomes

Primary Outcome Measures

The primary objective of this study is to compare the rates of diabetes remission over one year.

Secondary Outcome Measures

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).

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.

To examine the attitudes that patients, health care professionals, and insurance providers have toward the use of bariatric surgery to treat type 2 diabetes.

Full Information

NCT ID

NCT01040468

First Posted

December 24, 2009

Last Updated

August 17, 2016

Sponsor

University of Pennsylvania

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01040468

Brief Title

Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

Acronym

SOLID

Official Title

Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Roux-en-Y Gastric Bypass surgery

Arm Type

Active Comparator

Arm Description

Surgical intervention for weight loss

Arm Title

Laparoscopic Adjustable Gastric Banding surgery

Arm Type

Active Comparator

Arm Description

Surgical intervention for weight loss

Arm Title

Intensive Lifestyle Modification

Arm Type

Active Comparator

Arm Description

Lifestyle intervention for weight loss

Intervention Type

Procedure

Intervention Name(s)

Roux-en-Y Gastric Bypass surgery

Intervention Description

Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Adjustable Gastric Banding surgery

Intervention Description

Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.

Intervention Type

Behavioral

Intervention Name(s)

Intensive Lifestyle Modification

Intervention Description

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).

Primary Outcome Measure Information:

Title

The primary objective of this study is to compare the rates of diabetes remission over one year.

Time Frame

One year

Secondary Outcome Measure Information:

Title

Time Frame

One year

Title

Time Frame

One year

Title

To examine the attitudes that patients, health care professionals, and insurance providers have toward the use of bariatric surgery to treat type 2 diabetes.

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David B Sarwer, Ph.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas A Wadden, Ph.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Noel Williams, M.D.

Organizational Affiliation

University of Pennsylvania Department of Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania Center for Weight and Eating Disorders

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.med.upenn.edu/weight/research.shtml

Description

Center for Weight and Eating Disorders website

URL

http://www.pennmedicine.org/bariatrics/

Description

Bariatric Surgery Program at Penn website

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Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

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