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Improving Diabetes Through Lifestyle and Surgery (IDeaLS)

Primary Purpose

Obesity, Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gastric Banding
Medical Weight Loss
Gastric Bypass
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Diabetes

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Gastric Banding

Medical Weight Loss

Gastric Bypass

Arm Description

Laparoscopic Adjustable Gastric Banding

Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques

Roux-en-Y Gastric Bypass

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline to final data collection
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
Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months.

Full Information

First Posted
May 24, 2012
Last Updated
March 30, 2015
Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01667783
Brief Title
Improving Diabetes Through Lifestyle and Surgery
Acronym
IDeaLS
Official Title
Improving Diabetes Through Lifestyle and Surgery Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Obesity, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gastric Banding
Arm Type
Active Comparator
Arm Description
Laparoscopic Adjustable Gastric Banding
Arm Title
Medical Weight Loss
Arm Type
Active Comparator
Arm Description
Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques
Arm Title
Gastric Bypass
Arm Type
Active Comparator
Arm Description
Roux-en-Y Gastric Bypass
Intervention Type
Procedure
Intervention Name(s)
Gastric Banding
Intervention Description
Laparoscopic Adjustable Gastric Banding using the LapBand
Intervention Type
Behavioral
Intervention Name(s)
Medical Weight Loss
Other Intervention Name(s)
HMR meal replacements will be used
Intervention Description
Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians
Intervention Type
Procedure
Intervention Name(s)
Gastric Bypass
Intervention Description
Laparoscopic Roux-en-Y Gastric Bypass
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline to final data collection
Description
Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.
Time Frame
Average time 6 months
Secondary Outcome Measure Information:
Title
Change in insulin secretion
Description
Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months.
Time Frame
Average time 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne M. Clark, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31256356
Citation
Lee CJ, Florea L, Sears CL, Maruthur N, Potter JJ, Schweitzer M, Magnuson T, Clark JM. Changes in Gut Microbiome after Bariatric Surgery Versus Medical Weight Loss in a Pilot Randomized Trial. Obes Surg. 2019 Oct;29(10):3239-3245. doi: 10.1007/s11695-019-03976-4.
Results Reference
derived

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Improving Diabetes Through Lifestyle and Surgery

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