Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial
Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial
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DOI：
10.3389/fendo.2019.00348
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发表时间：
2019-06-05
影响因子：
5.2
通讯作者：
McCarter, James P.
中科院分区：
文献类型：
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作者：
Athinarayanan, Shaminie J.;Adams, Rebecca N.;McCarter, James P.
目的：低碳水化合物方法治疗糖尿病的长期可持续性研究有限。我们之前报道了一种新型数字监测持续护理干预（CCI）的有效性，包括营养酮症在1年时改善体重、血糖结果、血脂和肝脏标志物变化。在这里，我们评估的CCI在2 years.Materials and methods的影响：一个开放标签，非随机，对照研究，262和87名参与者与T2 D的CCI和常规护理（UC）组，分别入组。主要结局为2年时的保留、血糖控制和体重变化。次要结果包括身体成分的变化，肝脏，心血管，肾脏，甲状腺和炎症标志物，糖尿病药物的使用和疾病状态。结果：减少从基线到2年的CCI组导致意向治疗分析包括：HbA 1c，空腹血糖，空腹胰岛素，体重，收缩压，舒张压，甘油三酯，肝丙氨酸转氨酶和HDL-C增加。CCI组的脊柱骨密度没有变化。CCI参与者中任何血糖控制药物（不包括二甲双胍）的使用都有所下降（从55.7%降至26.8%），包括胰岛素（-62%）和磺脲类药物（-100%）。UC组在这些参数（尿酸和阴离子间隙除外）或糖尿病药物使用方面没有变化。在CCI组中也有糖尿病的消退（逆转，53.5%;缓解，17.6%），但在UC中没有。所有报告的改善均为p <0.00012。结论：CCI组在2年时对糖尿病和心脏代谢健康的多个临床标志物持续长期有益的效果，同时使用较少的药物。该干预措施在解决糖尿病和内脏肥胖方面也有效，对骨骼健康没有不良影响。
Purpose: Studies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. We previously reported the effectiveness of a novel digitally-monitored continuous care intervention (CCI) including nutritional ketosis in improving weight, glycemic outcomes, lipid, and liver marker changes at 1 year. Here, we assess the effects of the CCI at 2 years.Materials and methods: An open label, non-randomized, controlled study with 262 and 87 participants with T2D were enrolled in the CCI and usual care (UC) groups, respectively. Primary outcomes were retention, glycemic control, and weight changes at 2 years. Secondary outcomes included changes in body composition, liver, cardiovascular, kidney, thyroid and inflammatory markers, diabetes medication use and disease status.Results: Reductions from baseline to 2 years in the CCI group resulting from intent-to-treat analyses included: HbA1c, fasting glucose, fasting insulin, weight, systolic blood pressure, diastolic blood pressure, triglycerides, and liver alanine transaminase, and HDL-C increased. Spine bone mineral density in the CCI group was unchanged. Use of any glycemic control medication (excluding metformin) among CCI participants declined (from 55.7 to 26.8%) including insulin (-62%) and sulfonylureas (-100%). The UC group had no changes in these parameters (except uric acid and anion gap) or diabetes medication use. There was also resolution of diabetes (reversal, 53.5%; remission, 17.6%) in the CCI group but not in UC. All the reported improvements had p < 0.00012.Conclusion: The CCI group sustained long-term beneficial effects on multiple clinical markers of diabetes and cardiometabolic health at 2 years while utilizing less medication. The intervention was also effective in the resolution of diabetes and visceral obesity with no adverse effect on bone health.