糖化血紅蛋白（HbA1c）是血紅蛋白與葡萄糖結(jié)合的產(chǎn)物，可以反映患者近8～12周的血糖控制情況。雖然藥物可以有效降低2型糖尿病患者的HbA1c，但是藥物也可引起不良反應(yīng)、身體不適、經(jīng)濟(jì)成本增加、生活質(zhì)量下降，故需對(duì)運(yùn)動(dòng)和飲食等生活方式進(jìn)行干預(yù)，這些干預(yù)至少應(yīng)與標(biāo)準(zhǔn)用藥有相似的維持血糖控制效果。目前尚不清楚生活方式干預(yù)能否維持2型糖尿病患者的血糖控制。
2017年8月15日，《美國(guó)醫(yī)學(xué)會(huì)雜志》正式發(fā)表丹麥哥本哈根大學(xué)醫(yī)院、康復(fù)研究中心、派克研究所、腓特烈斯貝醫(yī)院、海萊烏醫(yī)院、丹麥糖尿病學(xué)會(huì)、歐登塞大學(xué)醫(yī)院的研究報(bào)告，發(fā)現(xiàn)大量高強(qiáng)度運(yùn)動(dòng)＋飲食干預(yù)可使2型糖尿病成人HbA1c輕度降低而降糖藥物使用減少。
該單中心單盲隨機(jī)對(duì)照研究于2015年4月～2016年8月從丹麥?zhǔn)锥即髤^(qū)和西蘭大區(qū)入組98例診斷時(shí)間＜10年的非胰島素依賴性2型糖尿病成年患者（平均年齡54.6±8.9歲；女性47例，占48%，平均基線HbA1c：6.7%），按2∶1隨機(jī)分為生活方式干預(yù)組（64例）或標(biāo)準(zhǔn)治療組（34例）。所有患者均接受標(biāo)準(zhǔn)治療，包括個(gè)體化咨詢和標(biāo)準(zhǔn)化目標(biāo)導(dǎo)向藥物治療。生活方式干預(yù)包括旨在維持體重指數(shù)≤25的飲食計(jì)劃、5～6周有氧運(yùn)動(dòng)（每次30～60分鐘）結(jié)合2～3次抗阻訓(xùn)練，并隨訪12個(gè)月。主要結(jié)局衡量指標(biāo)為0～12個(gè)月隨訪期間的HbA1c變化，等效分析根據(jù)意向治療人群預(yù)設(shè)為95%置信區(qū)間±0.4%，優(yōu)效分析根據(jù)次要結(jié)局衡量指標(biāo)為降糖用藥減少。
結(jié)果，93例參與者完成研究，0～12個(gè)月隨訪期間，生活方式干預(yù)組與標(biāo)準(zhǔn)治療組相比：
HbA1c平均濃度：6.65% → 6.34%比6.74% → 6.66%，組間平均變化差異為-0.26%（95%置信區(qū)間：-0.52%～-0.01%，P=0.15），不符合預(yù)設(shè)等效標(biāo)準(zhǔn)。
降糖用藥減少率：73.5%比26.4%，相差47.1%（95%置信區(qū)間：28.6～65.3，P<0.001），符合預(yù)設(shè)優(yōu)效標(biāo)準(zhǔn)。
不良事件：32例（最常見位肌肉骨骼疼痛或不適、輕度低血糖）比5例。
因此，對(duì)于2型糖尿病診斷時(shí)間＜10年的成人，生活方式干預(yù)（強(qiáng)化運(yùn)動(dòng)和飲食計(jì)劃）與標(biāo)準(zhǔn)治療相比，血糖控制雖然未達(dá)等效標(biāo)準(zhǔn)，但是有改善趨勢(shì)，且可減少用藥。需要進(jìn)一步研究評(píng)定這些結(jié)果的優(yōu)越性、可推廣性、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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