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Improving Diabetes Through Lifestyle and Surgery (IDeaLS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01667783
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Procedure: Gastric Banding Behavioral: Medical Weight Loss Procedure: Gastric Bypass Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Diabetes Through Lifestyle and Surgery Study
Study Start Date : August 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c from baseline to final data collection [ Time Frame: Average time 6 months ]
    Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.

Secondary Outcome Measures :
  1. Change in insulin secretion [ Time Frame: Average time 6 months ]
    Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667783

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Jeanne M. Clark, MD, MPH Johns Hopkins University
More Information

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 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Dr. Jeanne Clark, Johns Hopkins University:

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases