碳水化合物改良饮食与胰岛素增敏剂可减轻体重并调节代谢综合征指标（在EMPOWIR研究中：改善胰岛素抵抗女性的代谢状况）：一项针对中年体重增加的血糖正常女性的随机试验
Carbohydrate modified diet & insulin sensitizers reduce body weight & modulate metabolic syndrome measures in EMPOWIR (enhance the metabolic profile of women with insulin resistance): a randomized trial of normoglycemic women with midlife weight gain.
作者信息
Mogul Harriette R, Freeman Ruth, Nguyen Khoa, Frey Michael, Klein Lee-Ann, Jozak Sheila, Tanenbaum Karen
机构信息
Department of Medicine, Division of Endocrinology, New York Medical College, Valhalla, New York, United States of America.
Departments of Medicine and Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, New York, United States of America.
出版信息
PLoS One. 2014 Sep 26;9(9):e108264. doi: 10.1371/journal.pone.0108264. eCollection 2014.
RATIONALE
Progressive midlife weight gain is associated with multiple adverse health outcomes and may represent an early manifestation of insulin resistance in a distinct subset of women. Emerging data implicate hyperinsulinema as a proximate cause of weight gain and support strategies that attenuate insulin secretion.
OBJECTIVE
To assess a previously reported novel hypocaloric carbohydrate modified diet alone (D), and in combination with metformin (M) and metformin plus low-dose rosiglitazone (MR), in diverse women with midlife weight gain (defined as >20lbs since the twenties), normal glucose tolerance, and hyperinsulinemia.
PARTICIPANTS
46 women, mean age 46.6±1.0, BMI 30.5±0.04 kg/m2, 54.5% white, 22.7% black, 15.9% Hispanic, at 2 university medical centers.
METHODS
A dietary intervention designed to reduce insulin excursions was implemented in 4 weekly nutritional group workshops prior to randomization.
MAIN OUTCOME MEASURE
Change in 6-month fasting insulin. Pre-specified secondary outcomes were changes in body weight, HOMA-IR, metabolic syndrome (MS) measures, leptin, and adiponectin.
RESULTS
Six-month fasting insulin declined significantly in the M group: 12.5 to 8.0 µU/ml, p = .026. Mean 6-month weight decreased significantly and comparably in D, M, and MR groups: 4.7, 5.4, and 5.5% (p's.049, .002, and.032). HOMA-IR decreased in M and MR groups (2.5 to 1.6 and 1.9 to 1.3, p's = .054, .013). Additional improvement in MS measures included reduced waist circumference in D and MR groups and increased HDL in the D and M groups. Notably, mean fasting leptin did not decline in a subset of subjects with weight loss (26.15±2.01 ng/ml to 25.99±2.61 ng/ml, p = .907. Adiponectin increased significantly in the MR group (11.1±1.0 to 18.5±7.4, p<.001) Study medications were well tolerated.
CONCLUSIONS
These findings suggest that EMPOWIR's easily implemented dietary interventions, alone and in combination with pharmacotherapies that target hyperinsulinemia, merit additional investigation in larger, long-term studies.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00618072.
原理
中年体重逐渐增加与多种不良健康后果相关，可能是特定女性亚组胰岛素抵抗的早期表现。新出现的数据表明高胰岛素血症是体重增加的直接原因，并支持减轻胰岛素分泌的策略。
目的
评估一种先前报道的新型低热量碳水化合物改良饮食单独使用（D组），以及与二甲双胍（M组）和二甲双胍加小剂量罗格列酮（MR组）联合使用，对不同的中年体重增加（定义为自二十多岁起体重增加>20磅）、葡萄糖耐量正常且有高胰岛素血症的女性的影响。
参与者
46名女性，平均年龄46.6±1.0岁，体重指数30.5±0.04kg/m²，在2所大学医学中心，其中54.5%为白人，22.7%为黑人，15.9%为西班牙裔。
方法
在随机分组前，通过4次每周一次的营养小组研讨会实施旨在减少胰岛素波动的饮食干预。
主要观察指标
6个月空腹胰岛素的变化。预先设定的次要结局指标包括体重、胰岛素抵抗指数（HOMA-IR）、代谢综合征（MS）指标、瘦素和脂联素的变化。
结果
M组6个月空腹胰岛素显著下降：从12.5降至8.0µU/ml，p=0.026。D组、M组和MR组6个月平均体重显著且相当程度下降：分别为4.7%、5.4%和5.5%（p值分别为0.049、0.002和0.032）。M组和MR组的HOMA-IR下降（分别从2.5降至1.6和从1.9降至1.3，p值分别为0.054、0.013）。MS指标的进一步改善包括D组和MR组腰围减小，D组和M组高密度脂蛋白增加。值得注意的是，在一部分体重减轻的受试者中，平均空腹瘦素未下降（从26.15±2.01ng/ml降至25.99±2.61ng/ml，p=0.907）。MR组脂联素显著增加（从11.1±1.0升至18.5±7.4，p<0.001）。研究药物耐受性良好。
结论
这些发现表明，EMPOWIR的易于实施的饮食干预措施，单独使用以及与针对高胰岛素血症的药物疗法联合使用，值得在更大规模的长期研究中进一步调查。
试验注册
ClinicalTrials.gov NCT00618072
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