Back to resultsThe Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
Primary Purpose
Overweight, Diabetes Type 2
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Laparoscopic Sleeve Gastrectomy
Laparoscopic Roux-en-Y Gastric Bypass
Advanced Medical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Hadassah Medical Organization, Jerusalem, Israel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Advanced Medical Therapy Patients.
Bariatric Surgery Patients - Roux-en-Y gastric by- pass
Bariatric Surgery Patients -Laparoscopic sleeve gastrectomy
Arm Description
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.)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02036138
First Posted
January 8, 2014
Last Updated
February 27, 2019
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT02036138
Brief Title
The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Diabetes Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advanced Medical Therapy Patients.
Arm Type
Active Comparator
Arm Description
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.)
Arm Title
Bariatric Surgery Patients - Roux-en-Y gastric by- pass
Arm Type
Experimental
Arm Title
Bariatric Surgery Patients -Laparoscopic sleeve gastrectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Sleeve Gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Roux-en-Y Gastric Bypass
Intervention Type
Drug
Intervention Name(s)
Advanced Medical Therapy
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
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).
Description
The proportion of patients with a glycated hemoglobin level of less than 6% without diabetes medications.
Time Frame
12 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
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