Improving Diabetes Through Lifestyle and Surgery Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in HbA1c from baseline to final data collection
研究概览
简要总结
Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 30-40 kg/m2 at screening visit 1
- •Age 21-64 years
- •Insured by collaborating insurance plan (Employee Health Plan)
- •Type 2 Diabetes
- •Medically safe to undergo surgery and approved by a psychologist
- •Able to exercise at a moderate level
- •Able to give informed consent
- •Willing to accept randomization to each group
- •Able to communicate (both written and oral) in English
- •Willing to use reliable method of birth control during study and ≥18 months postop (if applicable)
排除标准
- •Prior bariatric surgery
- •Prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery, including large ventral hernia or previous large ventral hernia repair.
- •Weight loss of ≥ 5% of body weight in the past 6 months
- •Uncontrolled diabetes (HbA1c>8.5%)
- •Untreated severe diabetic retinopathy
- •Use of thiazolidinediones or insulin currently or within the past 3 months
- •Uncontrolled blood pressure (>160/100 -may be rescreened)
- •Estimated glomerular filtration rate (GFR)<30
- •Malignancy (except squamous or basal cell of the skin) in the past 5 years
- •MI, stroke or cardiovascular procedure within 12 months
- •Known HIV positive or use of anti-HIV therapy (HAART)
- •Unstable angina
- •Significant pulmonary disease with oxygen dependency
- •Chronic use (including in the past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium)
- •Use of prescription weight loss medication or over-the-counter orlistat in the past 6 months
- •Other serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss
- •History of severe depression requiring hospitalization in the past 12 months
- •Severe mental illness including bipolar disorder, schizophrenia or other psychotic disorders
- •Current bulimia nervosa
- •Unable or unwilling to use meal replacement products
- •Consumption of >14 alcoholic drinks/week or > 5 drinks on more than 2 occasions in the past 12 months
- •Use of illicit substances in the past 12 months
- •Cigarette or cigar smoking in the past 2 months
- •Pregnant or nursing within past 6 months
- •Plans to become pregnant within 2 years
- •Plans to relocate from the area within 1 year
- •Another member of household is a study participant or staff in the trial
结局指标
主要结局
Change in HbA1c from baseline to final data collection
时间窗: Average time 6 months
Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.
次要结局
- Change in insulin secretion(Average time 6 months)