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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Allison Goldfine, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01073020
First received: February 16, 2010
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Obesity
Procedure: Laparoscopic Adjustable Gastric Band
Procedure: Roux-en-Y Gastric Bypass (Surgery)
Other: Intensive Medical Diabetes & Weight Management
Device: Allergan Adjustable Gastric Band

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D)

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of suitable study design for larger trial of longer duration. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measurement of Metabolic Factors [ Time Frame: Baseline, 10 % weight loss, 1 year ] [ Designated as safety issue: No ]
  • Measurement of cardiovascular risk markers [ Time Frame: Baseline, 10% weight loss, 1 year ] [ Designated as safety issue: No ]
  • Quality of life and cost utility [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gastric Band vs Intensive Medical Diabetes & Weight Management 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?
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)
Active Comparator: RYGB vs Intensive Medical Diabetes & Weight Management 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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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/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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073020

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allison Goldfine, Study Co-Principal Investigator, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01073020     History of Changes
Other Study ID Numbers: 2009P-001610
Study First Received: February 16, 2010
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014