The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT02036138
First received: January 8, 2014
Last updated: January 12, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Non Morbid Obesity
Diabetes Type 2
Procedure: Laparoscopic Sleeve Gastrectomy
Procedure: Laparoscopic Roux-en-Y Gastric Bypass
Drug: Advanced Medical Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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) [ Time Frame: 12 MONTHS ] [ Designated as safety issue: No ]
    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). [ Time Frame: 12 MONTHS ] [ Designated as safety issue: No ]
    The proportion of patients with a glycated hemoglobin level of less than 6% without diabetes medications.


Estimated Enrollment: 168
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Advanced Medical Therapy Patients.
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.)
Drug: Advanced Medical Therapy
Experimental: Bariatric Surgery Patients - Roux-en-Y gastric by- pass Procedure: Laparoscopic Roux-en-Y Gastric Bypass
Experimental: Bariatric Surgery Patients -Laparoscopic sleeve gastrectomy Procedure: Laparoscopic Sleeve Gastrectomy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02036138     History of Changes
Other Study ID Numbers: 0035-13-HMO-CTIL
Study First Received: January 8, 2014
Last Updated: January 12, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014