Clinical trial NCT00428571: Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese Patients
Official title: Laparoscopic Bariatric Surgery for Treatment of Type 2 Diabetes in Obese Patients With End Organ Damage: A Prospective Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Bariatric surgery
Obesity
Laparoscopic gastric bypass
Laparoscopic adjustable gastric banding
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Diabetic control as assessed by HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Resolution of diabetes
timeFrame: 1 year
measure: Improvement in diabetic control and cardio-metabolic profile
timeFrame: 1 year
measure: Weight loss and decrease in BMI
timeFrame: 1 year
measure: Reduction in the usage of insulin or other diabetic drugs
timeFrame: 1 year
measure: Improvement in diabetic complications and end-organ damage
timeFrame: 1 year
measure: Improvement in health-related quality of life and depression scores
timeFrame: 1 year
measure: Utilization of resources and productivity losses
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: Centre for Minimal Access Surgery, McMaster University
name: Mehran Anvari, MB BS, PhD
role: PRINCIPAL_INVESTIGATOR
References: