Improving Diabetes Through Lifestyle and Surgery (IDeaLS)

August 8, 2024 updated by: Johns Hopkins University

Improving Diabetes Through Lifestyle and Surgery Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • HMR meal replacements will be used
Active Comparator: Gastric Bypass
Roux-en-Y Gastric Bypass
Procedure: Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average time 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average time 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Jeanne M. Clark, MD, MPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimated)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK089557
  • R01DK089557 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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