OverweightPhase 2/3NCT02036138
The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
A Phase 2/3 study testing Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Advanced Medical Therapy in people with Overweight and Diabetes Type 2, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The growing incidence of obesity and type2 DM globally is widely recognized as one of the most challenging contemporary threats to public health. Uncontrolled diabetes leads to macrovascular and microvascular complications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight, Diabetes Type 2
- What is being tested?
- Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Advanced Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jul 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, aged 18 years till 70.
- Diagnosed type2 DM.
- Glycated hemoglobin (HbA1c) of 8% or above in spite of treatment with 2 or more anti diabetic drugs (include insulin) for more than a year.
- HbA1c> 7.5% at the completion of the 8-12 weeks run in period.
- According to the judgment of their treating diabetologist, diabetes cannot be controlled to target by medical treatment alone.
- Female participants of child bearing potential must have negative pregnancy test in the screening visit and in the baseline visit
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- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Participant is willing and able to give informed consent for participation in the study.
- Willing to be randomized to any one of the 3 randomization arms.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Previous bariatric or any gastric or intestinal surgery.
- Contraindication to abdominal surgery.
- Patients with inflammatory bowel disease, severe small bowel adhesions, severe GERD or severe diaphragmatic hernia.
- Diabetes secondary to a specific disease (MODY, pancreatitis ,s/p pancreatectomy)
- History of type1 diabetes.
- C peptide< 0.5 ng/ml, and/or islet cell Autoantibodies.
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- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Significant renal impairment: eGFR<45 ml/min/BSA, or renal artery stenosis.
- Chronic uses of steroids or high dose of anti-inflammatory medications
- s/p Solid organ transplant.
- Acute Coronary syndrome (ACS) or Cerebro-vascular accident (CVA) or hospitalization for Unstable Angina Pectoris within the last 12 months.
- Uncontrolled hypertension: equal or above 180 mmHg systolic pressure or equal or above 110 mmHg diastolic pressure.
- Patients with a known hyper-coagulable state due to a genetic condition or a systemic disease such as protein S or protein C deficiency, SLE etc.
- Patient who require specific periodic gastric surveillance (e.g. gastritis, ulcers, neoplasm and intestinal Metaplasia) above the requirement in the general population
- Congestive Heart Failure NYHA 3-4..
- Portal Hypertension.
- Cirrhosis
- History of alcohol or drug abuse.
- Psychological incompetence that will interfere with the study.
- Patients that did not complete the preoperative evaluation.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The growing incidence of obesity and type2 DM globally is widely recognized as one of the most challenging contemporary threats to public health. Uncontrolled diabetes leads to macrovascular and microvascular complications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many patients. The current goal of medical treatment is to halt disease progression by reducing hyperglycemia, hypertension, dyslipidemia, and other cardiovascular risk factors. Despite improvements in pharmacotherapy, fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control. Observational studies have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and cardiovascular risk factors in severely obese patients with type 2 diabetes Few randomized, controlled trials have compared bariatric surgery with intensive medical therapy, particularly in moderately obese patients (defined as those having a BMI of 30 to 34.9) with type2 DM. Accordingly, many unanswered questions remain regarding the relative efficacy of bariatric surgery in patients with uncontrolled diabetes. This randomized, controlled, prospective multicenter study was designed to compare intensive medical therapy with surgical treatment (LRYGB or LSG) as a means of improving glycemic control in moderately obese patients (BMI 30-34.9) with type- 2 DM.
- Conditions
- Overweight, Diabetes Type 2
- Being tested
- Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass, Advanced Medical Therapy
- Medical subject headings
- Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Laparoscopic Roux-en-Y Gastric BypassProcedure or surgery
Advanced Medical TherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Advanced Medical Therapy Patients. | Active comparator | Advanced medical therapy is defined as the use of the latest lifestyle guidelines set forth by the American Diabetes Association to optimize weight loss and glycaemic management, frequent home monitoring/titration strategies, use of latest FDA approved drug therapy (incretin analogues, insulin sensitizers, etc.) Receives: Drug: Advanced Medical Therapy |
| Bariatric Surgery Patients - Roux-en-Y gastric by- pass | Experimental | Not described Receives: Procedure: Laparoscopic Roux-en-Y Gastric Bypass |
| Bariatric Surgery Patients -Laparoscopic sleeve gastrectomy | Experimental | Not described Receives: Procedure: Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of intensive medical therapy alone versus medical therapy combines with LRYGB or LSG in controlling type 2 DM in non-morbid obese patients (BMI 30-34.9)
The primary end point is the proportion of patients with a glycated hemoglobin level of less than 7% (with or without diabetes medications) 12 months after randomization.
Measured: 12 MONTHS
Secondary outcomes (1)
To assess the safety of intensive medical therapy alone versus medical therapy combines with LRYGB or LSG in diabetic non-morbid obese patients (BMI 30-34.9).
The proportion of patients with a glycated hemoglobin level of less than 6% without diabetes medications.
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036138
- Sponsor's protocol ID
- 0035-13-HMO-CTIL
- Status last verified
- Feb 2019
- First submitted
- 8 Jan 2014
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
- ClinicalTrials.gov ID
- NCT02036138
- Acronym / sponsor ID
- 0035-13-HMO-CTIL
- Conditions
- Overweight, Diabetes Type 2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 14 Jan 2014 (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.
The growing incidence of obesity and type2 DM globally is widely recognized as one of the most challenging contemporary threats to public health. Uncontrolled diabetes leads to macrovascular and microvascular complications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many patients. The current goal of medical treatment is to halt disease progression by reducing hyperglycemia, hypertension, dyslipidemia, and other cardiovascular risk factors. Despite improvements in pharmacotherapy, fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control. Observational studies have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and cardiovascular risk factors in severely obese patients with type 2 diabetes Few randomized, controlled trials have compared bariatric surgery with intensive medical therapy, particularly in moderately obese patients (defined as those having a BMI of 30 to 34.9) with type2 DM. Accordingly, many unanswered questions remain regarding the relative efficacy of bariatric surgery in patients with uncontrolled diabetes. This randomized, controlled, prospective multicenter study was designed to compare intensive medical therapy with surgical treatment (LRYGB or LSG) as a means of improving glycemic control in moderately obese patients (BMI 30-34.9) with type- 2 DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advanced Medical Therapy Patients. | Active comparator | Drug: Advanced Medical TherapyAdvanced medical therapy is defined as the use of the latest lifestyle guidelines set forth by the American Diabetes Association to optimize weight loss and glycaemic management, frequent home monitoring/titration strategies, use of latest FDA approved drug therapy (incretin analogues, insulin sensitizers, etc.) |
| Bariatric Surgery Patients - Roux-en-Y gastric by- pass | Experimental | Procedure: Laparoscopic Roux-en-Y Gastric Bypass |
| Bariatric Surgery Patients -Laparoscopic sleeve gastrectomy | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female, aged 18 years till 70.
- Diagnosed type2 DM.
- Glycated hemoglobin (HbA1c) of 8% or above in spite of treatment with 2 or more anti diabetic drugs (include insulin) for more than a year.
- HbA1c> 7.5% at the completion of the 8-12 weeks run in period.
- According to the judgment of their treating diabetologist, diabetes cannot be controlled to target by medical treatment alone.
Key exclusion criteria (21 listed)
- Previous bariatric or any gastric or intestinal surgery.
- Contraindication to abdominal surgery.
- Patients with inflammatory bowel disease, severe small bowel adhesions, severe GERD or severe diaphragmatic hernia.
- Diabetes secondary to a specific disease (MODY, pancreatitis ,s/p pancreatectomy)
- History of type1 diabetes.
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 |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Procedure or surgery | Bariatric Surgery Patients -Laparoscopic sleeve gastrectomy |
| Laparoscopic Roux-en-Y Gastric Bypass | Procedure or surgery | Bariatric Surgery Patients - Roux-en-Y gastric by- pass |
| Advanced Medical Therapy | Drug | Advanced Medical Therapy Patients. |
Primary outcome
To assess the efficacy of intensive medical therapy alone versus medical therapy combines with LRYGB or LSG in controlling type 2 DM in non-morbid obese patients (BMI 30-34.9)
Time frame: 12 MONTHS
The primary end point is the proportion of patients with a glycated hemoglobin level of less than 7% (with or without diabetes medications) 12 months after randomization.
1 secondary outcome
To assess the safety of intensive medical therapy alone versus medical therapy combines with LRYGB or LSG in diabetic non-morbid obese patients (BMI 30-34.9).
Time frame: 12 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Advanced Medical Therapy in people with Overweight and Diabetes Type 2, run by Hadassah Medical Organization at 1 site in Israel.
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 11 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 1 Mar 2019. 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 Israel. 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?
Results are not available in the source record.
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?
To assess the efficacy of intensive medical therapy alone versus medical therapy combines with LRYGB or LSG in controlling type 2 DM in non-morbid obese patients (BMI 30-34.9) (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2019.