Type 2 DiabetesPhase 3SOLIDNCT01040468

Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

A Phase 3 study testing Roux-en-Y Gastric Bypass surgery, Laparoscopic Adjustable Gastric Banding surgery and Intensive Lifestyle Modification in people with Type 2 Diabetes, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Roux-en-Y Gastric Bypass surgery, Laparoscopic Adjustable Gastric Banding surgery and Intensive Lifestyle Modification
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Mar 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes

Conditions: Type 2 Diabetes
Being tested: Roux-en-Y Gastric Bypass surgery, Laparoscopic Adjustable Gastric Banding surgery, Intensive Lifestyle Modification
Keywords: Type 2 Diabetes, Bariatric Surgery, Roux-en-Y Gastric Bypass, Gastric Banding, Obesity, Weight loss, Insulin sensitivity, GLP-1, Meal Challenge, Euglycemic Clamp
Medical subject headings: Diabetes Mellitus, Type 2, Obesity, Weight Loss, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Roux-en-Y Gastric Bypass surgeryProcedure or surgery
Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
Laparoscopic Adjustable Gastric Banding surgeryProcedure or surgery
Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
Intensive Lifestyle ModificationBehavioural
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).

Study groups in NCT01040468
Study group	Role	What they receive
Roux-en-Y Gastric Bypass surgery	Active comparator	Surgical intervention for weight loss Receives: Procedure: Roux-en-Y Gastric Bypass surgery
Laparoscopic Adjustable Gastric Banding surgery	Active comparator	Surgical intervention for weight loss Receives: Procedure: Laparoscopic Adjustable Gastric Banding surgery
Intensive Lifestyle Modification	Active comparator	Lifestyle intervention for weight loss Receives: Behavioral: Intensive Lifestyle Modification

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Mar 2015

First posted29 Dec 2009 (estimated)
Study startSep 2009
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01040468
Sponsor's protocol ID: 809984
Other IDs: 1RC1DK086132
Acronym: SOLID
Status last verified: Aug 2016
First submitted: 24 Dec 2009
Last updated: 19 Aug 2016
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes
ClinicalTrials.gov ID: NCT01040468
Acronym / sponsor ID: SOLID / 809984
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, Bariatric Surgery, Roux-en-Y Gastric Bypass, Gastric Banding, Obesity, Weight loss, Insulin sensitivity, GLP-1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Sep 2009
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 29 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Roux-en-Y Gastric Bypass surgery	Active comparator	Procedure: Roux-en-Y Gastric Bypass surgerySurgical intervention for weight loss
Laparoscopic Adjustable Gastric Banding surgery	Active comparator	Procedure: Laparoscopic Adjustable Gastric Banding surgerySurgical intervention for weight loss
Intensive Lifestyle Modification	Active comparator	Behavioral: Intensive Lifestyle ModificationLifestyle intervention for weight loss

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Roux-en-Y Gastric Bypass surgerySurgical intervention for weight loss. This is a one-year study and participants will attend five study visits.	Procedure or surgery	Roux-en-Y Gastric Bypass surgery
Laparoscopic Adjustable Gastric Banding surgerySurgical intervention for weight loss. This is a one-year study and participants will attend five study visits.	Procedure or surgery	Laparoscopic Adjustable Gastric Banding surgery
Intensive Lifestyle ModificationIntensive 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).	Behavioural	Intensive Lifestyle Modification

Primary outcome

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

3 secondary outcomes

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).
Time frame: One year
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.
Time frame: One year
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
Center for Weight and Eating Disorders websiteLink provided by the sponsor.
Bariatric Surgery Program at Penn websiteLink provided by the sponsor.

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David B Sarwer, Ph.D. principal investigator

University of Pennsylvania

Thomas A Wadden, Ph.D. principal investigator

University of Pennsylvania

Noel Williams, M.D. principal investigator

University of Pennsylvania Department of Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is to compare the rates of diabetes remission over one year. (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01040468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.