Overview

This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, obesity
Treatments laparoscopic adjustable gastric band, roux-en-y gastric bypass (surgery), intensive medical diabetes & weight management, allergan adjustable gastric band
Sponsor Allison Goldfine
Collaborator Brigham and Women's Hospital
Start date January 2010
End date December 2014
Trial size 88 participants
Trial identifier NCT01073020, 2009P-001610

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
laparoscopic adjustable gastric band Laparoscopic Adjustable Gastric Band (LABG)
Allergan Adjustable Gastric Band (Device) compared to Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
intensive medical diabetes & weight management
Intensive Medical Diabetes & Weight Management
allergan adjustable gastric band
Allergan Adjustable Gastric Band (Device) compared to Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
(Active Comparator)
roux-en-y gastric bypass (surgery) Roux-en-Y Gastric Bypass (RYGB)
Roux-en-Y Gastric Bypass (Surgery) versus Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
intensive medical diabetes & weight management
Intensive Medical Diabetes & Weight Management

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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.

Additional Information

Official title Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D)
Principal investigator Allison B. Goldfine, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Joslin Diabetes Center.