BACKGROUND Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. METHODS Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015-2016 and analyzed in 2017-2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. RESULTS FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%). CONCLUSIONS FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. TRIAL REGISTRATION This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).

中文翻译：

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家庭和跨学科干预预防T2D的效果：随机临床试验。

背景技术生活方式的改变可以降低患T2D的风险。然而，尚无研究评估涉及患者家庭的生活方式干预的效果。这项研究的目的是比较跨学科家庭（FI）与个体干预（II）对糖尿病前期患者糖代谢，胰岛素抵抗（IR），胰岛β细胞功能和心血管危险标志物的影响，以及衡量对家庭代谢风险的影响。方法随机临床试验（RCT）比较FI和II对糖尿病前期患者IR和胰腺β细胞功能的影响。有122名糖尿病前期受试者（和101名家庭成员）被随机分配至FI或II。数据收集于2015-2016年，并于2017-2018年进行了分析。FI集团得到了家人的支持，他们还收到了个性化的饮食和运动建议；患者及其家人每月参加一次生活方式改善计划。第二组收到个性化饮食和运动建议。随访时间为12个月。在基线，6个月和12个月时评估了葡萄糖，IR，胰腺β细胞功能和继发结局（身体组成和血脂状况）。结果FI组在12个月时血糖曲线下面积（AUC）从18,597±2611增至17,237±2792，p = 0.004）和Matsuda指数（从3.5±2.3增至4.7±3.5，p = 0.05）。II组在12个月时改善了处置指数（从1.5±0.4改善至1.9±0.73，p <.0001）。II组在6个月时体重和血脂水平的改善在12个月时就消失了，而FI组持续存在。各研究组之间长达12个月的依从性没有差异（FI 56％vs II 60％）。结论FI干预通过改善葡萄糖AUC，胰岛素敏感性和血脂状况而更为有效，此外，FI组家庭成员的代谢风险得以维持，而II组的风险则有所增加。试验注册本研究于2015年12月15日在临床试验网（NTC026365646）上进行了回顾性注册。