ObesityPhase 2/3IDeaLSNCT01667783
Improving Diabetes Through Lifestyle and Surgery
A Phase 2/3 study testing Gastric Banding, Medical Weight Loss and Gastric Bypass in people with Obesity and Type 2 Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Gastric Banding, Medical Weight Loss and Gastric Bypass
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: 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.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Gastric Banding, Medical Weight Loss, Gastric Bypass
- Keywords
- Obesity, Diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric BandingProcedure or surgery
Laparoscopic Adjustable Gastric Banding using the LapBand
Medical Weight LossBehavioural
Also called HMR meal replacements will be used
Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians
Gastric BypassProcedure or surgery
Laparoscopic Roux-en-Y Gastric Bypass
| Study group | Role | What they receive |
|---|---|---|
| Gastric Banding | Active comparator | Laparoscopic Adjustable Gastric Banding Receives: Procedure: Gastric Banding |
| Medical Weight Loss | Active comparator | Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques Receives: Behavioral: Medical Weight Loss |
| Gastric Bypass | Active comparator | Roux-en-Y Gastric Bypass Receives: Procedure: Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Average time 6 months
Secondary outcomes (1)
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.
Measured: Average time 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne M. Clark, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667783
- Sponsor's protocol ID
- DK089557
- Other IDs
- R01DK089557
- Acronym
- IDeaLS
- Status last verified
- Aug 2024
- First submitted
- 24 May 2012
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30997619Lee 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.
PubMed 31256356
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Through Lifestyle and Surgery Study
- ClinicalTrials.gov ID
- NCT01667783
- Acronym / sponsor ID
- IDeaLS / DK089557
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Obesity, Diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric Banding | Active comparator | Procedure: Gastric BandingLaparoscopic Adjustable Gastric Banding |
| Medical Weight Loss | Active comparator | Behavioral: Medical Weight LossMedical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques |
| Gastric Bypass | Active comparator | Procedure: Gastric BypassRoux-en-Y Gastric Bypass |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric BandingLaparoscopic Adjustable Gastric Banding using the LapBand | Procedure or surgery | Gastric Banding |
| Medical Weight LossAlso: HMR meal replacements will be usedWeight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians | Behavioural | Medical Weight Loss |
| Gastric BypassLaparoscopic Roux-en-Y Gastric Bypass | Procedure or surgery | Gastric Bypass |
Primary outcome
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.
1 secondary outcome
Change in insulin secretion
Time frame: Average time 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Results publication: PubMed 30997619Varma 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.
- Results publication: PubMed 31256356Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne M. Clark, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gastric Banding, Medical Weight Loss and Gastric Bypass in people with Obesity and Type 2 Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline to final data collection (time frame: Average time 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01667783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.