AzTrials
AzTrials

Type 2 Diabetes MellitusSLIMM-T2DNCT01073020

Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes

A study testing Allergan Adjustable Gastric Band Surgery, Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group and Roux-en-Y Gastric Bypass (RYGB) Surgery in people with Type 2 Diabetes Mellitus and Obesity, run by Joslin Diabetes Center at 2 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus, Obesity
What is being tested?
Allergan Adjustable Gastric Band Surgery, Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group and Roux-en-Y Gastric Bypass (RYGB) Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesUnited States
Study dates
Jan 2010to Nov 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Potential participants will be those with T2DM, with a diagnosis of diabetes of at least one year in duration,
  • BMI 30-45 kg/m^2 for the LAGB compared to intensive medical weight and diabetes management and BMI 30-42 kg/m^2 for LRYGB compared to intensive medical weight and diabetes management,
  • Age 21-65 years,
  • With a strong desire for substantial weight loss, who are free from active cardiovascular or other diseases that would render them unable to partake in a structured exercise program or to undergo a bariatric surgical procedure, and who are committed to life long medical and nutritional follow up.

Who cannot join

  • Detectable levels of glutamic acid decarboxylase (GAD) antibody or a history of diabetic ketoacidosis or uncontrolled T2DM (consistent fasting blood glucose >200 mg/dl or HbA1c above twice normal);
  • Previous gastrointestinal surgery, inflammatory bowel disease, esophageal diseases including severe intractable esophagitis, Barrett's Disease, esophageal dysmotility or other impaired gastric motility (gastroparesis), or hiatal hernia >3 cm in size, chronic or acute bleeding conditions including peptic ulcer disease, portal hypertension (gastric or esophageal varices), chronic pancreatitis, or cirrhosis of the liver;
  • Malignant or debilitating medical conditions, severe cardiopulmonary disease including uncontrolled hypertension (repeated systolic measures >160 or diastolic > 95 mm Hg on more than one day), unstable angina pectoris, recent myocardial infarction within 6 months, history of coronary artery bypass surgery or angioplasty, congestive heart failure, arrhythmia, stroke or transient ischemic attacks, urinary albumin excretion >300 mcg/mg creatinine and/or serum creatinine >1.5 mg/dL (permitting safety of increased dietary protein intake),
  • Any endocrine disorder other than T2DM or thyroid disease which is stable on replacement therapy, including Cushing's syndrome;
  • Any previous history of eating disorders, history of drug and/or alcohol abuse within 2 years of the screening visit, history of impaired mental status as defined by Diagnostic and Statistical Manual, 4th Edition (DSM-4) criteria and including, but not limited to active substance abuse, a history of schizophrenia, borderline personality disorder, uncontrolled depression, suicidal attempts within the past two years or current suicidal tendencies or ideations.
  • Subjects will be excluded if there is a history of significant weight loss (>3%) within the previous 3 months or participation in alternate medically supervised exercise or weight reduction program within the previous 3 months, or with use of prescription or over the counter weight reduction medications or supplements within one month of the Screening Visit and for the duration of study participation.
  • Women who are lactating, planning pregnancy, or unwilling to use contraception during the course of the trial.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D)

There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such procedures have greater effects on insulin secretion and insulin action than that expected from weight loss alone, which has led to the recent claim that such procedures may be useful as a primary treatment for T2DM in the moderately obese population. Concurrently, there have also been substantial advances in the non-surgical medical management of T2DM. As a result, the best treatment algorithm for T2DM patients with class 1 \& 2 obesity is increasingly controversial. This trial investigates the utility of currently practiced and available bariatric surgical procedures as compared with multidisciplinary intensive medical and weight management for the treatment of T2DM with class 1 and 2 obesity.

Read the detailed description

Primary Specific Aim 1: To evaluate the effectiveness of laparoscopic adjustable gastric band versus intensive medical and weight management in the treatment of T2DM.

There has been only one randomized control trial to date comparing surgical to medical management of T2DM in the less obese population, which demonstrated substantial superiority of the laparoscopic adjustable gastric band (LAGB) in the improvement of glycemic and metabolic measures. However, these findings remain controversial as the magnitude of weight loss in this study was far superior to that generally reported following LAGB. Thus, we propose a second prospective randomized trial to evaluate the effectiveness of intensive medical and weight management (IMWM) vs. LAGB in T2DM patients with BMI in the 30-42 kg/m^2 range. This range does extend LAGB surgery to BMI limits below those currently used in medical care, FDA Investigational Device Exemption (IDE) G090163. The primary outcome variable will be attaining glycemic control (as defined by fasting plasma glucose levels <126 mg/dL and HbA1c <6.5%) at one year of follow-up. The study was subsequently extended to 3 years, with the same outcome measures.

Primary Specific Aim 2: To evaluate the effectiveness of laparoscopic Roux-en-Y gastric bypass versus intensive medical and weight management in the treatment of T2DM.

Although observational studies and meta-analyses suggest rapid and sustained improvement or resolution of diabetes following laparoscopic Roux-en-Y gastric bypass (LRYGB), to date there has been no randomized trial directly comparing these effects to those produced by IMWM. We propose a prospective randomized trial comparing the effectiveness of IMWM vs. LRYGB in T2DM patients with BMI's in the 30-42 kg/m^2 range. This range extends LRYGB surgery to BMI limits below those currently used in medical care to explore the use of this type of surgical procedure in type 2 diabetes with lesser magnitude obesity. The primary outcome variable will be attaining glycemic control (as defined by fasting plasma glucose levels <126 mg/dL and HbA1c <6.5%) at one year of follow-up. The study was subsequently extended to 3 years, with the same outcome measures.

The trial is designed to allow for strong patient preference towards specific surgical procedures, and as such is designed as two parallel trials with each of the two surgical procedures judged against intensive medical weight management. Subjects without strong preference will be randomly assigned to one of the four study arms.

Secondary Specific Aims:

Determination of suitable study design: In addition to testing the effectiveness of current and available surgical techniques as compared to medical management, this trial will also test the utility of this trial design in future multi-institutional comparative effectiveness studies of these therapies, or alternatively, in future trials evaluating new surgical procedures being designed specifically for less obese T2DM patients.

Measurement of metabolic factors: Insulin secretion and action will be assessed during provocative mixed meal tolerance tests (MMTT) using the corrected incremental insulin response (CIR) and the composite insulin sensitivity index (CISI). MMTT will be performed in all groups at baseline and repeated at the time point of 10% weight loss (matched for weight loss), and at 12 months following randomization (matched for time).

Measurement of cardiovascular risk factors: Each group will be studied for evidence of changes in cardiovascular disease risk factors. Multiple surrogate measures of cardiovascular health will be compared, including blood pressure, fasting lipid profiles, endothelium-dependent vasodilatation and plasma will be collected for circulating markers of endothelial function. The study was subsequently extended to 3 years, with the same outcome measures.

Measurement of metabolic rate: Each group will be studied for change in energy expenditure and respiratory quotient using the non-invasive indirect calorimetry technique.

Quality of life and cost utility outcomes: Longitudinal measures of patient reported quality of life outcomes, and cost utility measures will also be collected to generate preliminary data for future studies.

Being tested
Allergan Adjustable Gastric Band Surgery, Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group, Roux-en-Y Gastric Bypass (RYGB) Surgery, Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group
Keywords
Type 2 Diabetes Mellitus, Obesity, Lifestyle, Bariatric Surgery, Laparoscopic Adjustable Gastric Band, Laparoscopic Roux-en-Y Gastric Bypass
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

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

  • Allergan Adjustable Gastric Band SurgeryDevice

  • Intensive Medical Diabetes & Weight Management (Why WAIT) - Band GroupOther

    Intensive Medical Diabetes \& Weight Management (Why WAIT) - Band Group

  • Roux-en-Y Gastric Bypass (RYGB) SurgeryProcedure or surgery

  • Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass GroupOther

    Intensive Medical Diabetes \& Weight Management (Why WAIT) - Bypass Group

Study groups in NCT01073020
Study groupRoleWhat they receive
Gastric Band vs Intensive Diabetes & Weight ManagementActive comparatorPatients will be randomized to receive either 1) laparoscopic placement of an adjustable gastric band (LAGB) or 2) treatment with an intensive medical and weight management (IMWM) program. LAGB will be placed using the "pars flaccida" technique. The Allergan laparoscopic band "LAP BAND" system will be utilized. LAGB ports will be placed in subcutaneous pockets in the right upper abdomen. The IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education.
Receives: Device: Allergan Adjustable Gastric Band Surgery; Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group
RYGB vs Intensive Diabetes & Weight ManagementActive comparatorPatients will be randomized to receive either 1) Roux-en-Y gastric bypass (RYGB) surgery or 2) treatment with an intensive medical and weight management (IMWM) program. RYGB will be performed using a 75 cm antecolic, ante-gastric Roux limb created with a 50 cm pancreaticobiliary limb. A 15-20 cc gastric pouch will be created lying along the lesser curve of the stomach, with division of the vagal trunks at the lower border of the pouch. The IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education.
Receives: Procedure: Roux-en-Y Gastric Bypass (RYGB) Surgery; Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group

What is being measured

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

  1. Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up.

    The primary outcome variable of both parallel trials will be the percent of patients attaining glycemic control (defined as fasting plasma glucose < 126 mg/dL and HbA1c < 6.5%) at three years of follow-up.

    Measured: 3 years

Secondary outcomes (3)

  1. Glycemic Control, as Measured by Hemoglobin A1c

    All participants had type 2 diabetes. Long-term diabetes control is typically evaluated in both clinical and research settings using the measurement of Hemoglobin A1c (a measure of glycated hemoglobin, proportional to average glucose levels over approximately 3 months). This endpoint (hemoglobin A1c) was measured at 3 years after intervention. Reported values are changes from baseline derived from the mixed effects model analysis, adjusted for baseline.

    Measured: 3 years

  2. Body Mass Index

    Change in body mass index 3 years after intervention

    Measured: 3 years

  3. Cardiovascular Risk

    UKPDS risk of coronary heart disease, reported as change from baseline

    Measured: 3 years

Timeline

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

  1. First posted22 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2014
  4. Study completionNov 2016

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01073020
Sponsor's protocol ID
2009P-001610
Acronym
SLIMM-T2D
Status last verified
May 2021
First submitted
16 Feb 2010
Last updated
28 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Lautz D, Halperin F, Goebel-Fabbri A, Goldfine AB. The great debate: medicine or surgery: what is best for the patient with type 2 diabetes? Diabetes Care. 2011 Mar;34(3):763-70. doi: 10.2337/dc10-1859. No abstract available.

    PubMed 21357363

  • Halperin F, Ding SA, Simonson DC, Panosian J, Goebel-Fabbri A, Wewalka M, Hamdy O, Abrahamson M, Clancy K, Foster K, Lautz D, Vernon A, Goldfine AB. Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):716-26. doi: 10.1001/jamasurg.2014.514.

    PubMed 24899464

  • Ding SA, Simonson DC, Wewalka M, Halperin F, Foster K, Goebel-Fabbri A, Hamdy O, Clancy K, Lautz D, Vernon A, Goldfine AB. Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2015 Jul;100(7):2546-56. doi: 10.1210/jc.2015-1443. Epub 2015 Apr 24.

    PubMed 25909333

  • Yu EW, Wewalka M, Ding SA, Simonson DC, Foster K, Holst JJ, Vernon A, Goldfine AB, Halperin F. Effects of Gastric Bypass and Gastric Banding on Bone Remodeling in Obese Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Feb;101(2):714-22. doi: 10.1210/jc.2015-3437. Epub 2015 Nov 24.

    PubMed 26600045

  • Panosian J, Ding SA, Wewalka M, Simonson DC, Goebel-Fabbri A, Foster K, Halperin F, Vernon A, Goldfine AB. Physical Activity in Obese Type 2 Diabetes After Gastric Bypass or Medical Management. Am J Med. 2017 Jan;130(1):83-92. doi: 10.1016/j.amjmed.2016.07.019. Epub 2016 Aug 20.

    PubMed 27555097

  • Simonson DC, Halperin F, Foster K, Vernon A, Goldfine AB. Clinical and Patient-Centered Outcomes in Obese Patients With Type 2 Diabetes 3 Years After Randomization to Roux-en-Y Gastric Bypass Surgery Versus Intensive Lifestyle Management: The SLIMM-T2D Study. Diabetes Care. 2018 Apr;41(4):670-679. doi: 10.2337/dc17-0487. Epub 2018 Feb 6.

    PubMed 29432125

  • Simonson DC, Vernon A, Foster K, Halperin F, Patti ME, Goldfine AB. Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial. Surg Obes Relat Dis. 2019 Dec;15(12):2052-2059. doi: 10.1016/j.soard.2019.03.038. Epub 2019 Apr 16.

    PubMed 31931977

  • Dreyfuss JM, Yuchi Y, Dong X, Efthymiou V, Pan H, Simonson DC, Vernon A, Halperin F, Aryal P, Konkar A, Sebastian Y, Higgs BW, Grimsby J, Rondinone CM, Kasif S, Kahn BB, Foster K, Seeley R, Goldfine A, Djordjilovic V, Patti ME. High-throughput mediation analysis of human proteome and metabolome identifies mediators of post-bariatric surgical diabetes control. Nat Commun. 2021 Nov 29;12(1):6951. doi: 10.1038/s41467-021-27289-2.

    PubMed 34845204

Questions about this trial

What is this clinical trial studying?

A study testing Allergan Adjustable Gastric Band Surgery, Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group and Roux-en-Y Gastric Bypass (RYGB) Surgery in people with Type 2 Diabetes Mellitus and Obesity, run by Joslin Diabetes Center at 2 sites in United States.

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 4 inclusion and 7 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up. (time frame: 3 years). 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 NCT01073020, which also lists 8 linked publications.

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 28 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in