热量不受限制的低碳水化合物、高脂肪饮食与高碳水化合物、低脂肪饮食对2型糖尿病和非酒精性脂肪性肝病的影响：一项随机对照试验。

Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial.

作者信息

Hansen Camilla Dalby, Gram-Kampmann Eva-Marie, Hansen Johanne Kragh, Hugger Mie Balle, Madsen Bjørn Stæhr, Jensen Jane Møller, Olesen Sara, Torp Nikolaj, Rasmussen Ditlev Nytoft, Kjærgaard Maria, Johansen Stine, Lindvig Katrine Prier, Andersen Peter, Thorhauge Katrine Holtz, Brønd Jan Christian, Hermann Pernille, Beck-Nielsen Henning, Detlefsen Sönke, Hansen Torben, Højlund Kurt, Thiele Maja Sofie, Israelsen Mads, Krag Aleksander

机构信息

Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense, Denmark (C.D.H., M.B.H., N.T., M.K., S.J., K.H.T., M.S.T.).

Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark (E.M.G., H.B., K.H.).

出版信息

Ann Intern Med. 2023 Jan;176(1):10-21. doi: 10.7326/M22-1787. Epub 2022 Dec 13.

DOI:10.7326/M22-1787

PMID:36508737

Abstract

BACKGROUND

It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated.

OBJECTIVE

To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet.

DESIGN

6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078).

SETTING

Odense University Hospital in Denmark from November 2016 until June 2020.

PARTICIPANTS

165 participants with T2DM.

INTERVENTION

Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins.

MEASUREMENTS

Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD.

RESULTS

The mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up.

LIMITATION

Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons.

CONCLUSION

Persons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention.

PRIMARY FUNDING SOURCE

Novo Nordisk Foundation.

摘要

背景

低碳水化合物、高脂肪（LCHF）饮食是否为2型糖尿病（T2DM）的一种可行治疗策略仍不明确，且其对非酒精性脂肪性肝病（NAFLD）的影响尚未得到研究。

目的

与高碳水化合物、低脂肪（HCLF）饮食相比，研究不限制热量摄入且无意减重的LCHF饮食对T2DM和NAFLD的影响。

设计

为期6个月的随机对照试验，随访3个月。（ClinicalTrials.gov：NCT03068078）。

地点

丹麦欧登塞大学医院，时间为2016年11月至2020年6月。

参与者

165例T2DM患者。

干预措施

两种不限制热量摄入的饮食：LCHF饮食，脂肪供能比为50%至60%，碳水化合物供能比低于20%，蛋白质供能比为25%至30%；HCLF饮食，碳水化合物供能比为50%至60%，脂肪供能比为20%至30%，蛋白质供能比为20%至25%。

测量指标

血糖控制、血脂水平、代谢标志物以及用于评估NAFLD的肝脏活检。

结果

平均年龄为56岁（标准差，10），58%为女性。与HCLF饮食相比，LCHF饮食的参与者糖化血红蛋白改善更明显（变化的平均差值，-6.1 mmol/mol [95%CI，-9.2至-3.0 mmol/mol]或-0.59% [CI，-0.87%至-0.30%]）且体重减轻更多（变化的平均差值，-3.8 kg [CI，-6.2至-1.4 kg]）。两组在6个月时高密度脂蛋白胆固醇均升高，甘油三酯均降低。LCHF饮食组低密度脂蛋白胆固醇的变化不如HCLF饮食组有利（变化的平均差值，0.37 mmol/L [CI，0.17至0.58 mmol/L]或14.3 mg/dL [CI，6.6至22.4 mg/dL]）。在NAFLD评估中未检测到组间有统计学意义的变化。9个月随访时变化未持续。