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Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese Patients

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Mehran Anvari, McMaster University
ClinicalTrials.gov Identifier:
NCT00428571
First received: January 26, 2007
Last updated: March 24, 2014
Last verified: March 2014

January 26, 2007
March 24, 2014
May 2007
April 2014   (final data collection date for primary outcome measure)
Diabetic control as assessed by HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Diabetic control as assessed by HbA1c
Complete list of historical versions of study NCT00428571 on ClinicalTrials.gov Archive Site
  • Resolution of diabetes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improvement in diabetic control and cardio-metabolic profile [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Weight loss and decrease in BMI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Reduction in the usage of insulin or other diabetic drugs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improvement in diabetic complications and end-organ damage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improvement in health-related quality of life and depression scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Utilization of resources and productivity losses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Resolution of diabetes
  • Improvement in diabetic control and cardio-metabolic profile
  • Weight loss and decrease in BMI
  • Reduction in the usage of insulin or other diabetic drugs
  • Improvement in diabetic complications and end-organ damage
  • Improvement in health-related quality of life and depression scores
  • Utilization of resources and productivity losses
Not Provided
Not Provided
 
Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese Patients
Laparoscopic Bariatric Surgery for Treatment of Type 2 Diabetes in Obese Patients With End Organ Damage: A Prospective Randomized Controlled Pilot Study

A large number of research studies on people who were morbidly obese (extremely overweight), and had bariatric surgery (anti-obesity surgery) have shown that patients who were diabetic before surgery often experienced significant improvement in their diabetes following the surgery. For some patients, blood glucose levels returned to the normal range, and they were able to stop taking all of their diabetes medications. For others, blood glucose levels improved, allowing them to reduce their diabetes medications.

This research study is being done to determine whether bariatric surgery can safely provide better control of diabetes symptoms in obese diabetics than continuing medical management (anti-diabetic drugs in combination with diet and lifestyle changes).

There are several different types of bariatric surgery currently being used to treat morbid obesity. Two of the most common techniques are gastric bypass and adjustable gastric banding. This study will be comparing these two surgical techniques to treatment with a combination of drugs, diet, and lifestyle changes for control of type 2 diabetes.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Procedure: laparoscopic gastric bypass surgery
    Laparoscopic Gastric Bypass Surgery
  • Procedure: laparoscopic adjustable gastric banding
    laparoscopic adjustable gastric banding
  • Procedure: Intensive Medical Management
    lifestyle, diet, medication optimization
  • Placebo Comparator: Intensive Medical Management
    Medical management of obesity including medication optimization and lifestyle and dietary advice.
    Intervention: Procedure: Intensive Medical Management
  • Active Comparator: Laparoscopic Gastric Bypass
    Intervention: Procedure: laparoscopic gastric bypass surgery
  • Active Comparator: Laparoscopic Adjustable Gastric Band
    Intervention: Procedure: laparoscopic adjustable gastric banding
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
72
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Residents of Southern Ontario, Canada
  • Obese (BMI 30 to < 40 kg/m2) patients who have had type 2 diabetes mellitus for more than 5 years, complicated by at least one of the following situations that persist despite adequate management efforts. The complicating situations are:

    • Severely reduced quality of life as assessed by the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire
    • Metabolic lability/instability, characterized by two or more episodes of severe hypoglycemia (≤ 3mmol/L) or severe hyperglycemia (≥ 25 mmol/L), or two or more hospital visits for diabetic complications over the last year
  • Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by:

    • Retinopathy — a minimum of a three step progression using the Early Treatment Diabetic Retinopathy Study (ETDRS) grading system, or an equivalent progression as certified by an ophthalmologist familiar with diabetic retinopathy or
    • Nephropathy — persistent or progressive macroalbuminuria (>20 mg albumin/mmol creatinine) over at least 12 months (beginning anytime within the past two years) despite the use of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) or
    • Neuropathy — persistent or progressing autonomic neuropathy (gastroparesis, postural hypotension, neuropathic bowel or bladder) or persistent or progressing severe peripheral painful neuropathy not responding to usual management (e.g., tricyclics, gabapentin, or carbamazepine)

Exclusion Criteria:

  • Less than 18 years of age or greater than 65 years of age
  • Unable to complete self and interviewer administered questionnaires in English
  • Incapable of providing informed consent
  • Any of the following medical conditions that may be associated with DM:

    • Recent positive history of myocardial infarction or coronary artery bypass graft or percutaneous transluminal angioplasty (less than 6 months)
    • Unstable angina pectoris
    • Recent clinically important ST-T changes on electrocardiogram (ECG) over the past year
    • Cardiac heart failure (New York Heart Association class III and IV; ejection fraction < 50%)
    • Frequent and persistent and unstable supra and ventricular arrhythmias,
    • Brain stroke, transient ischemic attack (TIA),
    • Major diabetic foot infections
    • Autonomic neuropathy resulting in orthostatic dysregulation
  • History of any psychiatric illness that would make the patient a poor candidate for bariatric surgery, as determined by the study psychiatrist
  • If female, pregnant or planning to become pregnant within next year
  • Clinically important cancer history (impact on either lifespan or performance of lap. bariatric surgery)
  • Clinically important abdominal or thoracic surgery that would impact the performance of laparoscopic bariatric procedure
  • Insulin dependence for more than 10 years
  • American Society of Anesthesiologists' classification of 4 or higher
  • Severe gastrointestinal reflux disease with Grade 3 or 4 esophagitis
  • History of pulmonary embolism or deep vein thrombosis
  • Presently taking either high-dose steroids or anticoagulants
  • Advanced nephropathy (Stage 4 or 5 - eGFR less than 30 ml/min)
  • Any other condition that, in the opinion of the study surgeons, would make the patient a poor candidate for bariatric surgery
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00428571
06-001
Not Provided
Mehran Anvari, McMaster University
Hamilton Health Sciences Corporation
Not Provided
Principal Investigator: Mehran Anvari, MB BS, PhD Centre for Minimal Access Surgery, McMaster University
McMaster University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP