Improving Diabetes Through Lifestyle and Surgery (IDeaLS)

This study is currently recruiting participants.
Verified August 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Jeanne Clark, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01667783
First received: May 24, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.


Condition Intervention Phase
Obesity
Type 2 Diabetes
Procedure: Gastric Banding
Behavioral: Medical Weight Loss
Procedure: Gastric Bypass
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Diabetes Through Lifestyle and Surgery Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in HbA1c from baseline to final data collection [ Time Frame: Average time 6 months ] [ Designated as safety issue: No ]
    Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.


Secondary Outcome Measures:
  • Change in insulin secretion [ Time Frame: Average time 6 months ] [ Designated as safety issue: No ]
    Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months.


Estimated Enrollment: 45
Study Start Date: August 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gastric Banding
Laparoscopic Adjustable Gastric Banding
Procedure: Gastric Banding
Laparoscopic Adjustable Gastric Banding using the LapBand
Active Comparator: Medical Weight Loss
Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques
Behavioral: Medical Weight Loss
Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians
Other Name: HMR meal replacements will be used
Active Comparator: Gastric Bypass
Roux-en-Y Gastric Bypass
Procedure: Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 30-40 kg/m2 at screening visit 1
  • Age 21-64 years
  • Insured by collaborating insurance plan (Employee Health Plan)
  • Type 2 Diabetes
  • Medically safe to undergo surgery and approved by a psychologist
  • Able to exercise at a moderate level
  • Able to give informed consent
  • Willing to accept randomization to each group
  • Able to communicate (both written and oral) in English
  • Willing to use reliable method of birth control during study and ≥18 months postop (if applicable)

Exclusion Criteria:

  • Prior bariatric surgery
  • Prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery, including large ventral hernia or previous large ventral hernia repair.
  • Weight loss of ≥ 5% of body weight in the past 6 months
  • Uncontrolled diabetes (HbA1c>8.5%)
  • Untreated severe diabetic retinopathy
  • Use of thiazolidinediones or insulin currently or within the past 3 months
  • Uncontrolled blood pressure (>160/100 -may be rescreened)
  • Estimated glomerular filtration rate (GFR)<30
  • Malignancy (except squamous or basal cell of the skin) in the past 5 years
  • MI, stroke or cardiovascular procedure within 12 months
  • Known HIV positive or use of anti-HIV therapy (HAART)
  • Unstable angina
  • Significant pulmonary disease with oxygen dependency
  • Chronic use (including in the past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium)
  • Use of prescription weight loss medication or over-the-counter orlistat in the past 6 months
  • Other serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss
  • History of severe depression requiring hospitalization in the past 12 months
  • Severe mental illness including bipolar disorder, schizophrenia or other psychotic disorders
  • Current bulimia nervosa
  • Unable or unwilling to use meal replacement products
  • Consumption of >14 alcoholic drinks/week or > 5 drinks on more than 2 occasions in the past 12 months
  • Use of illicit substances in the past 12 months
  • Cigarette or cigar smoking in the past 2 months
  • Pregnant or nursing within past 6 months
  • Plans to become pregnant within 2 years
  • Plans to relocate from the area within 1 year
  • Another member of household is a study participant or staff in the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667783

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Melisssa Scudder    410-550-4472      
Principal Investigator: Jeanne M. Clark, MD, MPH         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Jeanne M. Clark, MD, MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Dr. Jeanne Clark, Principal Investigator, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01667783     History of Changes
Other Study ID Numbers: DK089557, R01DK089557
Study First Received: May 24, 2012
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Obesity
Diabetes

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

ClinicalTrials.gov processed this record on April 17, 2014