- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428571
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Intensive Medical Management
Medical management of obesity including medication optimization and lifestyle and dietary advice.
|
lifestyle, diet, medication optimization
|
Active Comparator: Laparoscopic Gastric Bypass
|
Laparoscopic Gastric Bypass Surgery
|
Active Comparator: Laparoscopic Adjustable Gastric Band
|
laparoscopic adjustable gastric banding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diabetic control as assessed by HbA1c
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of diabetes
Time Frame: 1 year
|
1 year
|
Improvement in diabetic control and cardio-metabolic profile
Time Frame: 1 year
|
1 year
|
Weight loss and decrease in BMI
Time Frame: 1 year
|
1 year
|
Reduction in the usage of insulin or other diabetic drugs
Time Frame: 1 year
|
1 year
|
Improvement in diabetic complications and end-organ damage
Time Frame: 1 year
|
1 year
|
Improvement in health-related quality of life and depression scores
Time Frame: 1 year
|
1 year
|
Utilization of resources and productivity losses
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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