NCT00428571

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

7.9 years

First QC Date

January 26, 2007

Last Update Submit

April 13, 2016

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesBariatric surgeryObesityLaparoscopic gastric bypassLaparoscopic adjustable gastric banding

Outcome Measures

Primary Outcomes (1)

  • Diabetic control as assessed by HbA1c

    1 year

Secondary Outcomes (7)

  • Resolution of diabetes

    1 year

  • Improvement in diabetic control and cardio-metabolic profile

    1 year

  • Weight loss and decrease in BMI

    1 year

  • Reduction in the usage of insulin or other diabetic drugs

    1 year

  • Improvement in diabetic complications and end-organ damage

    1 year

  • +2 more secondary outcomes

Study Arms (3)

Intensive Medical Management

PLACEBO COMPARATOR

Medical management of obesity including medication optimization and lifestyle and dietary advice.

Procedure: Intensive Medical Management

Laparoscopic Gastric Bypass

ACTIVE COMPARATOR
Procedure: laparoscopic gastric bypass surgery

Laparoscopic Adjustable Gastric Band

ACTIVE COMPARATOR
Procedure: laparoscopic adjustable gastric banding

Interventions

laparoscopic gastric bypass surgeryPROCEDURE

Laparoscopic Gastric Bypass Surgery

Laparoscopic Gastric Bypass
laparoscopic adjustable gastric bandingPROCEDURE

laparoscopic adjustable gastric banding

Laparoscopic Adjustable Gastric Band
Intensive Medical ManagementPROCEDURE

lifestyle, diet, medication optimization

Intensive Medical Management

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehran Anvari, MB BS, PhD

    Centre for Minimal Access Surgery, McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 30, 2007

Study Start

May 1, 2007

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

CA(1)