235-OR：2 型糖尿病和肥胖症患者随机接受减肥手术与药物治疗 12 年后的生活质量和健康效用--ARMMS-T2D 研究

IF 6.2 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2024-07-19 DOI:10.2337/db24-235-or

DONALD C. SIMONSON, WILLIAM F. GOURASH, DAVID ARTERBURN, BO HU, SANGEETA R. KASHYAP, MARY-ELIZABETH PATTI, PHILIP SCHAUER, DAVID E. CUMMINGS, ANITA COURCOULAS, ALI AMINIAN, JOHN M. JAKICIC, ASHLEY H. VERNON, JOHN P. KIRWAN

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引用次数: 0

摘要

导言& 目的：T2D和肥胖与生活质量（QoL）和健康效用（HU）降低有关，但代谢/减肥手术（MBS）与医疗/生活方式干预（MLI）对这些结果的长期影响尚不清楚。研究方法我们对 ARMMS-T2D 研究中随机接受 MBS（RYGB、胃束带或袖状胃切除术；n = 152）与 MLI（n = 76）治疗的 228 名 T2D 和肥胖症患者进行了研究。在长达 12 年的时间里，每年测量一次 QoL（SF-36；包括身体成分评分 [PCS]、心理成分评分 [MCS] 和 8 个量表评分）和 HU（SF-6D）。结果显示基线年龄 = 49.2 ± 8.0 岁，68% 为女性，68% 为白人，体重指数 = 36.3 ± 3.4 kg/m²，血红蛋白 A1c = 8.7 ± 1.6%。MBS 的 PCS 在第 1 年有明显改善，12 年后仍高于 MLI（pamp &;lt;0.001），并与总体健康状况改善（pamp &;lt;0.001）、身体功能改善（p = 0.001）、精力充沛（p = 0.003）和疼痛减轻（p = 0.03）相关。MBS 与 MLI 相比，BMI 的变化更大（-18.6 ± 12.4% vs. -11.4 ± 10.9%，p &;lt;0.001），并且与 PCS 的变化显著相关（r = -0.43，p &;lt;0.001）。相比之下，MCS（p = 0.14）、情绪幸福感（p = 0.53）、角色情感（p = 0.43）和社会功能（p = 0.11）与基线相比没有变化，并且在 12 年中各组之间的情况相似。PCS 和 MCS 的变化与 HbA1c 的变化无关。在基线时服用胰岛素的患者中，随着时间的推移，停用胰岛素的患者的 PCS 较高（p < 0.001）。HU 在基线时为中等偏低（0.69 ± 0.08），12 年间两组患者的 HU 均无显著变化。结论：多巴胺苯丙胺类兴奋剂能持续减轻体重，并改善患者的 PCS，包括改善一般健康状况、身体机能、精力和减轻疼痛。停用胰岛素的患者的 PCS 改善幅度更大。随着时间的推移，各组之间在 MCS 或 HU 方面没有明显差异。这些差异可能有助于患有 T2D 和肥胖症的患者就最佳治疗方案做出明智的决定。披露 D.C. Simonson：股票/股东；Phase V Technologies, Inc.顾问小组；GI Windows。W.F. Gourash：无。D. Arterburn：无：无。B. Hu：无。S.R. Kashyap：研究支持；Fractyl Health, Inc.顾问团；GI Dynamics.研究支持；Janssen Pharmaceuticals, Inc.M. Patti：研究支持；Dexcom, Inc.顾问；Hanmi Pharm.Co., Ltd., MBX Biosciences.其他关系；Fractyl Health, Inc.顾问；AstraZeneca、Spruce Biosciences。P. Schauer：研究支持；Ethicon, Inc.其他关系；Ethicon, Inc.研究支持；Medtronic.其他关系；美敦力、诺和诺德。顾问团；礼来糖尿病、GI Dynamics、Heron。股票/股东；Mediflix、SE Healthcare。其他关系；Klens。顾问团；Persona、Keyron。股票/股东；Metabolic Health International LTD.D.E. Cummings：无。A. Courcoulas：研究支持；Allurion、礼来公司。A. Aminian：研究支持；美敦力。顾问；美敦力、Ethicon, Inc.研究支持；Ethicon, Inc.顾问团；礼来公司。J.M. Jakicic：研究支持；Epitomee。顾问团；Wondr Health。顾问；Education Initiatives, Inc.A.H. Vernon：无。J.P. Kirwan：无。资助国立卫生研究院（U01 DK114156）

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235-OR: Quality of Life and Health Utility 12 Years after Randomization to Bariatric Surgery vs. Medical Therapy in Patients with Type 2 Diabetes and Obesity—The ARMMS-T2D Study

Introduction & Objective: T2D and obesity are associated with reduced quality of life (QoL) and health utility (HU), but long-term effects of metabolic/bariatric surgery (MBS) vs. a medical/lifestyle intervention (MLI) on these outcomes are not known. Methods: We studied 228 patients with T2D and obesity who were randomized to MBS (RYGB, gastric band, or sleeve gastrectomy; n = 152) vs. MLI (n = 76) in the ARMMS-T2D study. QoL (SF-36; including Physical Component Score [PCS], Mental Component Score [MCS], and 8 scale scores) and HU (SF-6D) were measured annually for 12 yrs. Results: At baseline, age = 49.2 ± 8.0 yrs., 68% were female, 68% White, BMI = 36.3 ± 3.4 kg/m², HbA1c = 8.7 ± 1.6%. PCS improved significantly in MBS at year 1, remained higher vs. MLI over 12 yrs. (p < 0.001), and was associated with better general health (p < 0.001), physical function (p = 0.001), energy (p = 0.003), and reduced pain (p = 0.03). Change in BMI was greater after MBS vs. MLI (-18.6 ± 12.4% vs. -11.4 ± 10.9%, p < 0.001), and significantly correlated with change in PCS (r = -0.43, p < 0.001). In contrast, MCS (p = 0.14), emotional well-being (p = 0.53), role emotional (p = 0.43), and social functioning (p = 0.11) did not change from baseline and were similar between groups over 12 yrs. Changes in PCS and MCS were not associated with change in HbA1c. Among patients taking insulin at baseline, those who discontinued insulin had higher PCS (p < 0.001) over time. HU was moderately low at baseline (0.69 ± 0.08) and did not change significantly in either group during 12 yrs. Conclusions: MBS produced sustained weight loss that correlated with improved PCS, including better general health, physical function, energy, and less pain. PCS improved more in patients who discontinued insulin. There were no significant differences between groups over time in MCS or in HU. These differences may help patients with T2D and obesity make informed decisions about their best treatment options. Disclosure D.C. Simonson: Stock/Shareholder; Phase V Technologies, Inc. Advisory Panel; GI Windows. W.F. Gourash: None. D. Arterburn: None. B. Hu: None. S.R. Kashyap: Research Support; Fractyl Health, Inc. Advisory Panel; GI Dynamics. Research Support; Janssen Pharmaceuticals, Inc. M. Patti: Research Support; Dexcom, Inc. Consultant; Hanmi Pharm. Co., Ltd., MBX Biosciences. Other Relationship; Fractyl Health, Inc. Consultant; AstraZeneca, Spruce Biosciences. P. Schauer: Research Support; Ethicon, Inc. Other Relationship; Ethicon, Inc. Research Support; Medtronic. Other Relationship; Medtronic, Novo Nordisk. Advisory Panel; Lilly Diabetes, GI Dynamics, Heron. Stock/Shareholder; Mediflix, SE Healthcare. Other Relationship; Klens. Advisory Panel; Persona, Keyron. Stock/Shareholder; Metabolic Health International LTD. D.E. Cummings: None. A. Courcoulas: Research Support; Allurion, Eli Lilly and Company. A. Aminian: Research Support; Medtronic. Consultant; Medtronic, Ethicon, Inc. Research Support; Ethicon, Inc. Advisory Panel; Eli Lilly and Company. J.M. Jakicic: Research Support; Epitomee. Advisory Panel; Wondr Health. Consultant; Education Initiatives, Inc. A.H. Vernon: None. J.P. Kirwan: None. Funding National Institutes of Health (U01 DK114156)

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来源期刊

Diabetes 医学-内分泌学与代谢

CiteScore

12.50

自引率

2.60%

发文量

1968

审稿时长

1 months

期刊介绍： Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.