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Improving Diabetes Through Lifestyle and Surgery (IDeaLS)

This study is currently recruiting participants.
Verified August 2012 by Johns Hopkins University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
  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:

U.S. FDA Resources

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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 May 19, 2013