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
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Procedure: laparoscopic gastric bypass surgery
Procedure: laparoscopic adjustable gastric banding
Procedure: Intensive Medical Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Bariatric Surgery for Treatment of Type 2 Diabetes in Obese Patients With End Organ Damage: A Prospective Randomized Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Diabetic control as assessed by HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: May 2007
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Intensive Medical Management
Medical management of obesity including medication optimization and lifestyle and dietary advice.
Procedure: Intensive Medical Management
lifestyle, diet, medication optimization
Active Comparator: Laparoscopic Gastric Bypass Procedure: laparoscopic gastric bypass surgery
Laparoscopic Gastric Bypass Surgery
Active Comparator: Laparoscopic Adjustable Gastric Band Procedure: laparoscopic adjustable gastric banding
laparoscopic adjustable gastric banding

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428571

Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Mehran Anvari, MB BS, PhD Centre for Minimal Access Surgery, McMaster University
  More Information

No publications provided

Responsible Party: Mehran Anvari, Dr., McMaster University
ClinicalTrials.gov Identifier: NCT00428571     History of Changes
Other Study ID Numbers: 06-001
Study First Received: January 26, 2007
Last Updated: March 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Type 2 Diabetes
Bariatric surgery
Obesity
Laparoscopic gastric bypass
Laparoscopic adjustable gastric banding

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014