强化运动并控制饮食可减少糖尿病用药

　　糖化血红蛋白（HbA1c）是血红蛋白与葡萄糖结合的产物，可以反映患者近8～12周的血糖控制情况。虽然药物可以有效降低2型糖尿病患者的HbA1c，但是药物也可引起不良反应、身体不适、经济成本增加、生活质量下降，故需对运动和饮食等生活方式进行干预，这些干预至少应与标准用药有相似的维持血糖控制效果。目前尚不清楚生活方式干预能否维持2型糖尿病患者的血糖控制。

　　2017年8月15日，《美国医学会杂志》正式发表丹麦哥本哈根大学医院、康复研究中心、派克研究所、腓特烈斯贝医院、海莱乌医院、丹麦糖尿病学会、欧登塞大学医院的研究报告，发现大量高强度运动＋饮食干预可使2型糖尿病成人HbA1c轻度降低而降糖药物使用减少。

　　该单中心单盲随机对照研究于2015年4月～2016年8月从丹麦首都大区和西兰大区入组98例诊断时间＜10年的非胰岛素依赖性2型糖尿病成年患者（平均年龄54.6±8.9岁；女性47例，占48%，平均基线HbA1c：6.7%），按2∶1随机分为生活方式干预组（64例）或标准治疗组（34例）。所有患者均接受标准治疗，包括个体化咨询和标准化目标导向药物治疗。生活方式干预包括旨在维持体重指数≤25的饮食计划、5～6周有氧运动（每次30～60分钟）结合2～3次抗阻训练，并随访12个月。主要结局衡量指标为0～12个月随访期间的HbA1c变化，等效分析根据意向治疗人群预设为95%置信区间±0.4%，优效分析根据次要结局衡量指标为降糖用药减少。

　　结果，93例参与者完成研究，0～12个月随访期间，生活方式干预组与标准治疗组相比：

  • HbA1c平均浓度：6.65% → 6.34%比6.74% → 6.66%，组间平均变化差异为-0.26%（95%置信区间：-0.52%～-0.01%，P=0.15），不符合预设等效标准。

  • 降糖用药减少率：73.5%比26.4%，相差47.1%（95%置信区间：28.6～65.3，P<0.001），符合预设优效标准。

  • 不良事件：32例（最常见位肌肉骨骼疼痛或不适、轻度低血糖）比5例。

　　因此，对于2型糖尿病诊断时间＜10年的成人，生活方式干预（强化运动和饮食计划）与标准治疗相比，血糖控制虽然未达等效标准，但是有改善趋势，且可减少用药。需要进一步研究评定这些结果的优越性、可推广性、持久性。

JAMA. 2017 Aug 15;318(7):637-646.

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard AS, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M.

Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; CopenRehab, University of Copenhagen, Copenhagen, Denmark; Parker Institute, Copenhagen, Denmark; Frederiksberg Hospital, Copenhagen, Denmark; Herlev Hospital, Herlev, Denmark; AstraZeneca, Molndal, Sweden; Danish Diabetes Academy, Odense University Hospital, Odense, Denmark.

QUESTION: Can an intensive lifestyle intervention achieve glycemic control comparable with standard care in patients with type 2 diabetes?

FINDINGS: In this randomized clinical trial of 98 adults with type 2 diabetes diagnosed for less than 10 years, and which was designed to assess equivalence, the lifestyle intervention vs standard care resulted in a mean change in hemoglobin A1c level of -0.31% vs -0.04%, respectively. The 95% CI around the difference (-0.52% to -0.01%) exceeded the prespecified equivalence margin of ±0.4%.

MEANING: An intensive lifestyle intervention did not meet the criterion for equivalence for glycemic control, but the direction of findings suggests potential benefit.

IMPORTANCE: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes.

OBJECTIVE: To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes.

DESIGN, SETTING, AND PARTICIPANTS: Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n=64) or the standard care group (n=34).

INTERVENTIONS: All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months.

MAIN OUTCOMES AND MEASURES: Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication.

RESULTS: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P=.15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group.

CONCLUSIONS AND RELEVANCE: Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02417012.

PMID: 28810024

DOI: 10.1001/jama.2017.10169

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