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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01073020
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : May 6, 2021
Last Update Posted : June 28, 2021
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Joslin Diabetes Center

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Device: Allergan Adjustable Gastric Band Surgery Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group Procedure: Roux-en-Y Gastric Bypass (RYGB) Surgery Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D)
Actual Study Start Date : January 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gastric Band vs Intensive Diabetes & Weight Management

Patients 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.

Device: Allergan Adjustable Gastric Band Surgery
Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group
Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group

Active Comparator: RYGB vs Intensive Diabetes & Weight Management

Patients 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.

Procedure: Roux-en-Y Gastric Bypass (RYGB) Surgery
Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group
Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group




Primary Outcome Measures :
  1. Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up. [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Glycemic Control, as Measured by Hemoglobin A1c [ Time Frame: 3 years ]
    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.

  2. Body Mass Index [ Time Frame: 3 years ]
    Change in body mass index 3 years after intervention

  3. Cardiovascular Risk [ Time Frame: 3 years ]
    UKPDS risk of coronary heart disease, reported as change from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073020


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Brigham and Women's Hospital
Investigators
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Principal Investigator: Allison B. Goldfine, MD Joslin Diabetes Center
Principal Investigator: Ashley Vernon, MD Brigham and Women's Hospital
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01073020    
Other Study ID Numbers: 2009P-001610
First Posted: February 22, 2010    Key Record Dates
Results First Posted: May 6, 2021
Last Update Posted: June 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Joslin Diabetes Center:
Type 2 Diabetes Mellitus
Obesity
Lifestyle
Bariatric Surgery
Laparoscopic Adjustable Gastric Band
Laparoscopic Roux-en-Y Gastric Bypass
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases