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

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ClinicalTrials.gov Identifier: NCT01073020
Recruitment Status : Active, not recruiting
First Posted : February 22, 2010
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Joslin Diabetes Center

Tracking Information
First Submitted Date  ICMJE February 16, 2010
First Posted Date  ICMJE February 22, 2010
Last Update Posted Date February 15, 2018
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2010)
The primary outcome variable of both parallel trials 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. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01073020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2010)
  • Determination of suitable study design for larger trial of longer duration. [ Time Frame: 1 year ]
  • Measurement of Metabolic Factors [ Time Frame: Baseline, 10 % weight loss, 1 year ]
  • Measurement of cardiovascular risk markers [ Time Frame: Baseline, 10% weight loss, 1 year ]
  • Quality of life and cost utility [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes
Official Title  ICMJE Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Obesity
Intervention  ICMJE
  • Procedure: Laparoscopic Adjustable Gastric Band
    Allergan Adjustable Gastric Band (Device) compared to Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
    Other Names:
    • Laparoscopic Adjustable Gastric Band (LABG)
    • Why WAIT?
  • Procedure: Roux-en-Y Gastric Bypass (Surgery)
    Roux-en-Y Gastric Bypass (Surgery) versus Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
    Other Names:
    • Roux-en-Y Gastric Bypass (RYGB)
    • Why WAIT?
  • Other: Intensive Medical Diabetes & Weight Management
    Intensive Medical Diabetes & Weight Management
  • Device: Allergan Adjustable Gastric Band
    Allergan Adjustable Gastric Band (Device) compared to Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
Study Arms  ICMJE
  • Active Comparator: Gastric Band vs Intensive Medical Diabetes & Weight Management
    Interventions:
    • Procedure: Laparoscopic Adjustable Gastric Band
    • Other: Intensive Medical Diabetes & Weight Management
    • Device: Allergan Adjustable Gastric Band
  • Active Comparator: RYGB vs Intensive Medical Diabetes & Weight Management
    Interventions:
    • Procedure: Roux-en-Y Gastric Bypass (Surgery)
    • Other: Intensive Medical Diabetes & Weight Management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 11, 2014)
88
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2010)
100
Estimated Study Completion Date  ICMJE March 2018
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/m2 for the LAGB compared to intensive medical weight and diabetes management and BMI 30-42 kg/m2 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 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 by DSM-IV (Diagnostic and Statistical Manual, 4th Edition) 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01073020
Other Study ID Numbers  ICMJE 2009P-001610
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joslin Diabetes Center
Study Sponsor  ICMJE Joslin Diabetes Center
Collaborators  ICMJE Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: Allison B. Goldfine, MD Joslin Diabetes Center
Principal Investigator: Ashley Vernon, MD Brigham and Women's Hospital
PRS Account Joslin Diabetes Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP