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治験 NCT00428571（対象：2型糖尿病）は中止です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese Patients 20 生活習慣 食事療法
Laparoscopic Bariatric Surgery for Treatment of Type 2 Diabetes in Obese Patients With End Organ Damage: A Prospective Randomized Controlled Pilot Study
- 06-001
Bariatric surgery
Obesity
Laparoscopic gastric bypass
Laparoscopic adjustable gastric banding
| 参加グループ/群 | 介入/治療法 |
|---|---|
プラセボ対照薬Intensive Medical Management Medical management of obesity including medication optimization and lifestyle and dietary advice. | Intensive Medical Management lifestyle, diet, medication optimization |
実薬対照薬Laparoscopic Gastric Bypass | laparoscopic gastric bypass surgery Laparoscopic Gastric Bypass Surgery |
実薬対照薬Laparoscopic Adjustable Gastric Band | Laparoscopic adjustable gastric banding laparoscopic adjustable gastric banding |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Diabetic control as assessed by HbA1c | 1 year |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 | |
Improvement in health-related quality of life and depression scores | 1 year | |
Utilization of resources and productivity losses | 1 year |
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)
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
Hamilton Health Sciences CorporationOntario