Type 2 DiabetesNCT00428571
Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese Patients
A study testing laparoscopic gastric bypass surgery, laparoscopic adjustable gastric banding and Intensive Medical Management in people with Type 2 Diabetes, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- laparoscopic gastric bypass surgery, laparoscopic adjustable gastric banding and Intensive Medical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- laparoscopic gastric bypass surgery, laparoscopic adjustable gastric banding, Intensive Medical Management
- Keywords
- Type 2 Diabetes, Bariatric surgery, Obesity, Laparoscopic gastric bypass, Laparoscopic adjustable gastric banding
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic gastric bypass surgeryProcedure or surgery
Laparoscopic Gastric Bypass Surgery
laparoscopic adjustable gastric bandingProcedure or surgery
laparoscopic adjustable gastric banding
Intensive Medical ManagementProcedure or surgery
lifestyle, diet, medication optimization
| Study group | Role | What they receive |
|---|---|---|
| Intensive Medical Management | Placebo comparator | Medical management of obesity including medication optimization and lifestyle and dietary advice. Receives: Procedure: Intensive Medical Management |
| Laparoscopic Gastric Bypass | Active comparator | Not described Receives: Procedure: laparoscopic gastric bypass surgery |
| Laparoscopic Adjustable Gastric Band | Active comparator | Not described Receives: Procedure: laparoscopic adjustable gastric banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic control as assessed by HbA1c
Measured: 1 year
Secondary outcomes (7)
Resolution of diabetes
Measured: 1 year
Improvement in diabetic control and cardio-metabolic profile
Measured: 1 year
Weight loss and decrease in BMI
Measured: 1 year
Reduction in the usage of insulin or other diabetic drugs
Measured: 1 year
Improvement in diabetic complications and end-organ damage
Measured: 1 year
Improvement in health-related quality of life and depression scores
Measured: 1 year
Utilization of resources and productivity losses
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehran Anvari, McMaster University
- Investigators
- Mehran Anvari, MB BS, PhD, Principal investigator, Centre for Minimal Access Surgery, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428571
- Sponsor's protocol ID
- 06-001
- Status last verified
- Apr 2016
- First submitted
- 26 Jan 2007
- Last updated
- 14 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Bariatric Surgery for Treatment of Type 2 Diabetes in Obese Patients With End Organ Damage: A Prospective Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT00428571
- Acronym / sponsor ID
- 06-001
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Bariatric surgery, Obesity, Laparoscopic gastric bypass, Laparoscopic adjustable gastric banding
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive Medical Management | Placebo comparator | Procedure: Intensive Medical ManagementMedical management of obesity including medication optimization and lifestyle and dietary advice. |
| Laparoscopic Gastric Bypass | Active comparator | Procedure: laparoscopic gastric bypass surgery |
| Laparoscopic Adjustable Gastric Band | Active comparator | Procedure: laparoscopic adjustable gastric banding |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by:
Key exclusion criteria (23 listed)
- 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:
- History of any psychiatric illness that would make the patient a poor candidate for bariatric surgery, as determined by the study psychiatrist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic gastric bypass surgeryLaparoscopic Gastric Bypass Surgery | Procedure or surgery | Laparoscopic Gastric Bypass |
| laparoscopic adjustable gastric bandinglaparoscopic adjustable gastric banding | Procedure or surgery | Laparoscopic Adjustable Gastric Band |
| Intensive Medical Managementlifestyle, diet, medication optimization | Procedure or surgery | Intensive Medical Management |
Primary outcome
Diabetic control as assessed by HbA1c
Time frame: 1 year
7 secondary outcomes
Resolution of diabetes
Time frame: 1 year
Improvement in diabetic control and cardio-metabolic profile
Time frame: 1 year
Weight loss and decrease in BMI
Time frame: 1 year
Reduction in the usage of insulin or other diabetic drugs
Time frame: 1 year
Improvement in diabetic complications and end-organ damage
Time frame: 1 year
Improvement in health-related quality of life and depression scores
Time frame: 1 year
Utilization of resources and productivity losses
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehran Anvari, MB BS, PhD principal investigator
Centre for Minimal Access Surgery, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic gastric bypass surgery, laparoscopic adjustable gastric banding and Intensive Medical Management in people with Type 2 Diabetes, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic control as assessed by HbA1c (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.