Impact of Bariatric Surgery on Long-term Diabetes Remission and Complications

减肥手术对长期糖尿病缓解和并发症的影响

• 批准号: 8672631
• 负责人: David Eric Arterburn
• 金额: $ 56.02万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-15 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8672631
• 关键词: Address; Adult; Age; Amputation; Angioplasty; Area; Blood Pressure; Blood Vessels; Body mass index; Cardiac; Clinical; Complications of Diabetes Mellitus; Computerized Medical Record; Coronary Artery Bypass; Data; Data Sources; Development; Diabetes Mellitus; Diabetic Retinopathy; Disease Outcome; Disease remission; Exposure to; Eye diseases; Gastrectomy; Gastric Bypass; Glomerular Filtration Rate; Goals; Health; Health Planning; Heterogeneity; Individual; Infarction; Insurance; Intervention; Ischemia; Kidney Diseases; Lipids; Longitudinal Studies; Medical; Medicare/Medicaid; Memory; Metabolic; Microvascular Dysfunction; Minority Groups; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Observational Study; Operative Surgical Procedures; Outcome; Patients; Peripheral Vascular Diseases; Pharmacological Treatment; Procedures; Randomized; Relapse; Research; Risk; Series; Site; Smoking Status; Stents; Stratification; Stroke; Subgroup; System; Testing; Time; Transient Ischemic Attack; Ulcer; United Kingdom; Vascular Diseases; bariatric surgery; cardiovascular risk factor; clinically relevant; clinically significant; cohort; comparative effectiveness; epidemiology study; experience; follow-up; glycemic control; health care delivery; improved; innovation; macrovascular disease; macular edema; novel; prospective; treatment effect

DESCRIPTION (provided by applicant): The goal of our proposed study is to investigate whether a transient period of diabetes remission after roux-en- y gastric bypass surgery (RYGB) induces a sustained benefit in long-term microvascular and macrovascular disease outcomes. Our project would be an expansion of our recent research in this area in which we utilize electronic medical record data from four large, integrated health plans and care delivery systems in the HMO Research Network (HMORN) to examine short and long-term health outcomes of over 9,000 severely obese individuals with type 2 diabetes who have undergone RYGB over an 18-year period (1996-2014). The longitudinal cohorts and rich, clinical and administrative data available at these HMORN sites are crucial for conducting valid, robust longitudinal studies of bariatric surgery because extensive adjustments, stratification, and sub-setting that are required. For our new application presented here, we propose to extend and expand our prior cohort in terms of size, duration of follow-up, and the number of clinically-important outcomes addressed. We will increase the follow- up period for our initial cohort by six years to further improve our ability to characterize the longer-term complications of diabetes. We will increase the size of our cohort by tapping a previously unutilized data source - H1,000 adults with diabetes who received RYGB at Group Health Cooperative. Finally, our major innovation will be to explore the legacy effect of RYGB through a series of analyses that characterize long- term, micro- and macrovascular outcomes across three patient groups: those who do not remit their diabetes after RYGB; those who experience durable diabetes remission after RYGB; and those who relapse their diabetes after an initial remission. Microvascular outcomes will include the following: (i) renal disease: decreased glomerular filtration rate and micro/macroalbuminura; and (ii) eye disease: diabetic retinopathy and clinically significant macular edema. Macrovascular outcomes will include the following: (i) cardiac ischemia, infarction, angioplasty/stent, or coronary bypass surgery; (ii) stroke or transient ischemic attack and (iii) peripheral vascular disease-related ulceration, revascularization or amputation This study will test the following novel hypotheses: (1) severely obese patients who experience a durable remission of diabetes after RYGB will have fewer incident microvascular and macrovascular complications compared to those who do not remit their diabetes, (2) the beneficial effects of a transient period of diabetes remission after RYGB will persist after diabetes relapse (legacy effect); i.e., relapsing patients will experience fewer complications than those who do not remit their diabetes after RYGB, and (3) the duration of diabetes remission and/or control after RYGB will be significantly associated with the risk of incident microvascular and macrovascular complications.

描述（由申请人提供）：我们拟议的研究的目的是调查roux-en-y胃搭桥手术（RYGB）后糖尿病缓解的短暂时期是否会导致长期的微血管和大血管疾病成果的持续益处。我们的项目将扩展到我们最近在该领域的研究，在该领域中，我们从HMO研究网络（HMORN）中的四个大型，综合的健康计划和护理服务系统中利用电子病历数据，以检查9,000多名2型糖尿病患者的短期和长期健康结果，他们在18年期间（​​1996年至2014年）患有RYGB的2型糖尿病患者。在这些HMORN站点可用的纵向人群以及丰富的临床和行政数据对于进行减肥手术的有效，可靠的纵向研究至关重要，因为所需的广泛调整，分层和子设定是至关重要的。对于此处介绍的新申请，我们建议在规模，随访时间以及临床上最重要的结果数量方面扩展和扩展我们先前的队列。我们将最初队列的后续时期增加六年，以进一步提高我们表征糖尿病长期并发症的能力。我们将通过攻击先前未利用的数据来源来增加队列的大小-H1,000名患有在集团健康合作社接受RYGB的糖尿病的成年人。最后，我们的主要创新将是通过一系列分析来探索RYGB的遗产效应，这些分析表征了三个患者群体的长期，微血管和大血管结局的特征：那些在RYGB之后不延长糖尿病的人； RYGB后经历耐用糖尿病的人；和那些在初次缓解后复发糖尿病的人。微血管结局将包括以下内容：（i）肾脏疾病：肾小球滤过率降低和微/大藻瘤； （ii）眼病：糖尿病性视网膜病和临床上显着的黄斑水肿。大血管结局将包括以下内容：（i）心脏缺血，梗塞，血管成形术/支架或冠状动脉搭桥手术； (ii) stroke or transient ischemic attack and (iii) peripheral vascular disease-related ulceration, revascularization or amputation This study will test the following novel hypotheses: (1) severely obese patients who experience a durable remission of diabetes after RYGB will have fewer incident microvascular and macrovascular complications compared to those who do not remit their diabetes, (2) the beneficial effects of a RYGB后糖尿病缓解的短暂性周期将在糖尿病复发后持续存在（遗产效应）；即，复发患者的并发症将少于 那些在RYGB之后不释放其糖尿病的人，以及（3）RYGB后糖尿病缓解和/或对照的持续时间将与出现的微血管和大血管并发症的风险显着相关。