Lifestyle Modification versus Bariatric Surgery for Type 2 Diabetes

生活方式改变与减肥手术治疗 2 型糖尿病

基本信息

批准号：
7934547
负责人：
DAVID B SARWER
金额：
$ 50.75万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-20 至 2013-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7934547
关键词：
Address Area Attitude Bariatrics Behavior Therapy Benefits and Risks Blood Glucose Body Weight decreased Body mass index Camping Case Study Cell physiology Cholecystitis Comorbidity Data Diabetes Mellitus Dietary intake Disease remission Endocrinologist Fasting Future Gastric Bypass Glycosylated hemoglobin A Health Personnel Health Professional Hypoglycemia Individual Insurance Intervention Investigation Longitudinal Studies Measures Meta-Analysis Modeling Morbid Obesity Non-Insulin-Dependent Diabetes Mellitus Obesity Operative Surgical Procedures Outcome Participant Patients Persons Pharmaceutical Preparations Pharmacotherapy Physical activity Physicians Pilot Projects Positioning Attribute Primary Care Physician Procedures Provider Quality of life Randomized Randomized Controlled Trials Research Resolution Risk Safety Surgical complication Surveys Testing Time United States National Institutes of Health Wages Weight bariatric surgery base cardiovascular risk factor comparative effectiveness comparative efficacy cost cost effectiveness design diabetes control diabetic diabetic patient effectiveness research experience glucagon-like peptide 1 glycemic control improved indexing insulin sensitivity intervention effect primary outcome programs prospective randomized trial response secondary outcome trial comparing weight loss intervention willingness

项目摘要

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area "Comparative Effectiveness Research" (05) and the specific Challenge Topic "Understanding the Effects of Bariatric Surgery on Type 2 Diabetes and Cardiovascular Risk Factors" (05-DK-102). Bariatric surgery is currently the most effective and durable treatment for extreme obesity. Furthermore, as suggested by several studies and meta-analyses, it is associated with improvements or resolution of several obesity-related comorbidities (particularly type 2 diabetes) in a large majority of individuals. For these and other reasons, there is great enthusiasm among some professional groups to use bariatric surgical interventions to treat type 2 diabetes in individuals with a body mass index (BMI) < 35 kg/m2, which is the lowest BMI recommended by the National Institutes of Health and reimbursed by most insurance companies. Despite the potential promise of bariatric surgery as a treatment for type 2 diabetes for these individuals, several unanswered questions remain. First, there have been no randomized controlled trials that compared the efficacy of Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable banding (LAGB), with each other, and with intensive non-surgical weight loss intervention, for ameliorating type 2 diabetes. Second, the mechanisms by which RYGB and LAGB improve gylcemic control are not well understood. Third, in the absence of more definitive understanding of these mechanisms, the level of acceptance of surgical treatment of type 2 diabetes among practitioners (i.e., endocrinologists and primary care physicians), as well as obese diabetics themselves, is unknown. The proposed study is designed to address these questions. In a randomized controlled trial, we propose to study diabetes remission and changes in insulin sensitivity and b-cell function in diabetic individuals with a BMI of 30 to and 40 kg/m2 who are randomly assigned to RYGB, LAGB or intensive non-surgical weight management. We also propose to study attitudes toward and acceptability of these bariatric procedures among endocrinologists and primary care physicians, who are likely to provide referrals for this future group of potential patients. We also will assess the acceptability of bariatric surgery among obese type 2 diabetics themselves. The large weight losses seen with bariatric surgery are often associated with improvements or resolution of several obesity-related comorbidities, including type 2 diabetes. The proposed project is designed to compare improvements in diabetes control in obese diabetic individuals who are assigned by chance to one of three groups: 1) Roux-en-Y gastric bypass; 2) laparoscopic adjustable gastric banding; or 3) intensive non-surgical weight management. In addition, the project will study the level of acceptance of surgical treatment of type 2 diabetes among physicians, health care providers, and insurance companies.

描述（由申请人提供）：此申请涉及广泛的挑战领域“比较有效性研究”（05）和特定的挑战主题“了解减肥手术对2型糖尿病和心血管危险因素的影响”（05-DK-102）。减肥手术目前是极端肥胖症的最有效和耐用的治疗方法。此外，正如多个研究和荟萃分析所暗示的那样，它与大多数个体的几种与肥胖相关的合并症（尤其是2型糖尿病）的改善或解决有关。由于这些和其他原因，一些专业团体之间非常热情使用减肥手术干预措施来治疗体重指数（BMI）<35 kg/m2的个体中的2型糖尿病，这是美国国立卫生研究院最低的BMI，并由大多数保险公司推荐。尽管减肥手术作为这些人的2型糖尿病治疗的潜在有望，但仍有几个未解决的问题。首先，没有随机对照试验比较了Roux-en-Y胃旁路（RYGB）和腹腔镜可调式带（LAGB）的疗效，彼此之间以及强烈的非手术减肥干预措施，以改善2型2型糖尿病。其次，RYGB和LAGB改善Gylcepic Control的机制尚不清楚。第三，在对这些机制的缺乏更明确的理解的情况下，从业人员（即内分泌学家和初级保健医生）对2型糖尿病的手术治疗的接受程度以及肥胖的糖尿病学本身是未知的。拟议的研究旨在解决这些问题。在一项随机对照试验中，我们建议研究糖尿病的缓解以及BMI为30至40 kg/m2的糖尿病患者的胰岛素敏感性和B细胞功能的变化，这些糖尿病患者被随机分配给RYGB，LAGB或严格的非外科体重管理。我们还建议研究内分泌学家和初级保健医生对这些减肥手术的态度和可接受性，他们可能会为未来的潜在患者提供推荐。我们还将评估肥胖2型糖尿病患者本身的减肥手术的可接受性。减肥手术看到的大量减肥通常与几种与肥胖相关的合并症（包括2型糖尿病）的改善或分辨率有关。拟议的项目旨在比较肥胖的糖尿病患者的糖尿病控制的改善，这些肥胖糖尿病患者被偶然地分配给了三组之一：1）roux-en-y y-y胃旁路； 2）可腹腔镜可调式胃束带；或3）密集的非手术体重管理。此外，该项目将研究医生，医疗保健提供者和保险公司中2型糖尿病的手术治疗的接受程度。