Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.
Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.
Contemp Clin Trials. 2019 Mar;78:101-106. doi: 10.1016/j.cct.2019.01.005. Epub 2019 Jan 6.
Currently, there is a lack of data on effective lifestyle recommendations for normal-weight diabetics (NWD), who can represent up to 1 in 5 individuals with Type II Diabetes Mellitus (T2DM). NWD is especially prevalent in Asian populations and the elderly. Specific exercise treatment recommendations are needed for patients with normal-weight diabetes (NWD), as those in this category face higher mortality rates than overweight and obese diabetics. Standard T2DM treatment recommends aerobic training; however, performing aerobic training alone may not be appropriate for NWD and strength training may be a more effective treatment recommendation.
While it is known that strength and aerobic training are beneficial in obese diabetics, there is currently insufficient evidence to recommend this regimen in NWD. The Strength Training Regimen for Normal Weight Diabetics (STRONG-D) study aims to determine the best exercise regimen for NWD and address the current lack of appropriate physical activity recommendations for this population. The primary goal of this study is to determine whether strength training aids glycemic control better than aerobic training in NWD.
STRONG-D is a three-arm randomized controlled trial designed to compare the clinical effectiveness of structured strength training only, aerobic training only, and combination (strength + aerobic) training sessions, modeled after the intervention in the Health Benefits of Aerobic and Resistance Training in T2DM patients (HART-D) study. Potential participants meeting eligibility criteria of HbA1c values of 6.5% to 13.0% and BMI of 18.5 kg/m to 25 kg/m will be enrolled. After randomization, participants will begin a 9-month exercise intervention. The primary outcomes will be HbA1c levels. The secondary endpoints will include physical fitness, body composition measured by Dual X-Ray Absorptiometry (DXA) scans, and leg strength and endurance measured by Biodex testing. Initial follow-up visits will occur at 3 months, 6 months, and 9 months. To determine the long-term effects of the exercise intervention, passive follow-up will continue via electronic health records (EHR) until a 24-month follow-up visit. A total of 282 participants will be randomized into the three study arms determine the clinically significant differences between strength-only, aerobic-only and combination regimens.
目前，对于正常体重的糖尿病患者（NWD），缺乏有效的生活方式建议数据，而这些患者可能占二型糖尿病（T2DM）患者的 1/5。NWD 在亚洲人群和老年人中尤为普遍。由于这一人群的死亡率高于超重和肥胖的糖尿病患者，因此需要为正常体重糖尿病患者（NWD）提供特定的运动治疗建议。标准的 T2DM 治疗建议进行有氧运动训练；然而，对于 NWD 患者，单独进行有氧运动训练可能并不合适，力量训练可能是更有效的治疗建议。
虽然已知力量训练和有氧运动对肥胖的糖尿病患者有益，但目前尚无足够的证据推荐 NWD 患者采用这种方案。《正常体重糖尿病患者的力量训练方案（STRONG-D）》研究旨在确定 NWD 的最佳运动方案，并解决目前针对这一人群缺乏适当身体活动建议的问题。本研究的主要目标是确定力量训练是否比有氧运动更能改善 NWD 的血糖控制。
STRONG-D 是一项三臂随机对照试验，旨在比较仅进行结构性力量训练、仅进行有氧运动训练以及同时进行力量训练和有氧运动训练（基于 HART-D 研究中的干预措施）三种方案在 NWD 患者中的临床效果。符合纳入标准的患者，糖化血红蛋白（HbA1c）值为 6.5%至 13.0%，体重指数（BMI）为 18.5kg/m2 至 25kg/m2，将被纳入研究。随机分组后，参与者将开始为期 9 个月的运动干预。主要结局指标将是 HbA1c 水平。次要终点指标将包括身体机能、双能 X 射线吸收仪（DXA）扫描测量的身体成分以及 Biodex 测试测量的腿部力量和耐力。初始随访在 3 个月、6 个月和 9 个月时进行。为了确定运动干预的长期效果，通过电子健康记录（EHR）进行被动随访，直至 24 个月随访。共有 282 名参与者被随机分配到三个研究组，以确定力量训练、有氧运动和联合方案之间的临床显著差异。
