Improving Diabetes Through Lifestyle and Surgery
IDeaLS
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 obesity
Started Aug 2012
Typical duration for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedAugust 12, 2024
August 1, 2024
2.5 years
May 24, 2012
August 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Average time 6 months
Secondary Outcomes (1)
Change in insulin secretion
Average time 6 months
Study Arms (3)
Gastric Banding
ACTIVE COMPARATORLaparoscopic Adjustable Gastric Banding
Medical Weight Loss
ACTIVE COMPARATORMedical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques
Gastric Bypass
ACTIVE COMPARATORRoux-en-Y Gastric Bypass
Interventions
Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Related Publications (2)
Varma S, Lee CJ, Brown TT, Maruthur NM, Schweitzer M, Magnuson T, Kamel I, Clark JM. Comparative Effects of Medical Versus Surgical Weight Loss on Body Composition: a Pilot Randomized Trial. Obes Surg. 2019 Aug;29(8):2503-2510. doi: 10.1007/s11695-019-03879-4.
PMID: 30997619RESULTLee 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.
PMID: 31256356RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeanne M. Clark, MD, MPH
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2012
First Posted
August 17, 2012
Study Start
August 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
August 12, 2024
Record last verified: 2024-08