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: 8293825
• 负责人: David Eric Arterburn
• 金额: $ 66.06万
• 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/8293825
• 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 Angiopathies; 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; 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. PUBLIC HEALTH RELEVANCE: The UKPDS and the DCCT studies have previously shown that transient periods of relatively better glycemic control resulted in significant long-term benefits in terms of reduced microvascular and macrovascular complications, even though the levels of glycemic control eventually became identical between intervention and control subjects when the randomization period ended. The prolonged beneficial effects of improved glycemic control observed in these studies have been termed the "legacy effect" or "metabolic memory." The goal of our proposed study is to investigate whether there is a legacy effect induced by bariatric surgery.

描述（由申请人提供）：我们提出的研究目的是调查roux-en- y胃旁路手术（RYGB）后糖尿病的短暂缓解是否会对微血管和大血管疾病的长期预后产生持续的益处。我们的项目将是我们最近在这一领域的研究的扩展，我们利用HMO研究网络（HMORN）中四个大型综合健康计划和医疗服务系统的电子病历数据来检查超过9000名严重肥胖的2型糖尿病患者的短期和长期健康结果，这些患者在18年期间（1996-2014）接受了RYGB。这些HMORN站点的纵向队列和丰富的临床和管理数据对于进行有效、可靠的减肥手术纵向研究至关重要，因为需要进行广泛的调整、分层和亚组。对于我们在这里提出的新应用，我们建议在规模、随访时间和临床重要结果的数量方面扩展和扩大我们先前的队列。我们将把初始队列的随访时间延长6年，以进一步提高我们描述糖尿病长期并发症的能力。我们将利用以前未利用的数据源——在集团卫生合作社接受RYGB治疗的1,000名糖尿病成人患者——来扩大我们队列的规模。最后，我们的主要创新将是通过一系列分析来探索RYGB的遗留效应，这些分析描述了三组患者的长期、微血管和大血管结局：RYGB后未缓解糖尿病的患者；RYGB后糖尿病持续缓解者；以及那些在最初的缓解后又复发的人。微血管结果将包括以下内容：(i)肾脏疾病：肾小球滤过率和微/大白蛋白减少；（ii）眼病：糖尿病视网膜病变和临床上明显的黄斑水肿。大血管结局将包括以下内容：(i)心脏缺血、梗死、血管成形术/支架或冠状动脉搭桥手术；（ii）中风或短暂性脑缺血发作和（iii）周围血管疾病相关的溃疡、血运重建术或截肢。本研究将检验以下新的假设：(1)与未缓解糖尿病的严重肥胖患者相比，RYGB后糖尿病持续缓解的患者微血管和大血管并发症发生率更低；(2)RYGB后糖尿病短暂缓解的有益效果将在糖尿病复发后持续存在（遗留效应）；也就是说，复发的病人比