NCT04527965已完成不适用
Liver Fat as a Dietary Target for Treating Cardiometabolic Disorders in Prediabetes and Type 2 Diabetes: a Randomized Study (NAFLDiet)
Uppsala University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年8月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Between-group changes in liver fat content between baseline and month 12
研究概览
简要总结
The overall aim of this study is to investigate the long-term impact of a customized diet aimed at reducing liver fat specifically and a healthy Nordic diet on ectopic fat (liver, pancreatic and visceral) and cardiometabolic risk in individuals with prediabetes and type 2 diabetes (T2D).
详细描述
Randomized controlled studies investigating the impact of replacing dietary carbohydrates with polyunsaturated fat (PUFA) on liver fat content and cardiometabolic risk in individuals with prediabetes and T2D are lacking. Also, the effects of a Healthy Nordic Diet on liver fat content and glycemic control have not be investigated. This study therefore aims to:
- Investigate the effects of the diets on liver fat content (primary aim)
- Investigate the effects of the diets on pancreatic fat, visceral fat, lean tissue, glycemic and lipid control
- Investigate the effects of the diets on plasma markers of de novo lipogenesis (DNL) and desaturation (i.e. stearoyl-Coenzyme desaturase 1, SCD-1) as well as on hepatic DNL using MRI spectroscopy
- Investigate gene-diet interactions, especially if common gene variants (e.g. in PNPLA3) known to increase liver fat and dyslipidemia, may modify the dietary effects.
- Perform lipidomic analyses to identify potential mechanistic pathways that may associate with diet-induced changes in liver fat, pancreatic fat, visceral fat, insulin sensitivity, dyslipidemia or DNL
Our hypothesis is that a customized diet will effectively reduce liver fat through suppression of hepatic DNL and SCD-1 activity, and thereby improve atherogenic dyslipidemia, insulin resistance and hyperglycemia in individuals with prediabetes and T2D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •30-75 years
- •BMI 25-40
- •T2D (duration ≤10 years, no insulin treatment) or prediabetes (ADA definition 2019) without diagnosed cardiovascular disease (CVD) during the last 2 years (e.g. myocardial infarction, stroke or angina pectoris)
排除标准
- •Alcohol intake >20 g/day
- •Unwillingness to follow a new prescribed diet for 1 year
- •Diet-induced weight loss (≥10%) the preceding 3 months of screening
- •Malignant disease
- •Severe kidney and liver disease
- •Heart failure or other severe CVD
- •claustrophobia or metal parts in the body (MRI)
结局指标
主要结局
Between-group changes in liver fat content between baseline and month 12
时间窗: 12 months
Assessed by magnetic resonance imaging (MRI)
次要结局
- Between-group changes in systolic blood pressure between baseline and month 12(12 months)
- Between-group changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) between baseline and month 12(12 months)
- Between-group changes in fasting serum insulin between baseline and month 12(12 months)
- Between-group changes in pancreatic fat between baseline and month 12(12 months)
- Between-group changes in body weight between baseline and month 12(12 months)
- Between-group changes in glycated hemoglobin (HbA1c) between baseline and month 12(12 months)
- Between-group changes in pulse-wave velocity (PWV) between baseline and month 12(12 months)
- Between-group values in PWV at month 12(12 months)
- Between-group changes in visceral adipose tissue mass between baseline and month 12(12 months)
- Between-group changes in total body fat mass between baseline and month 12(12 months)
- Between-group changes in circulating inflammatory markers (CRP, Tumor Necrosis Factor Alpha-receptor 1 and 2, Interleukin-1 receptor antagonist, Fibroblast growth factor 21) between baseline and month 12(12 months)
- Between-group changes in flow-mediated dilation (FMD) between baseline and month 12(12 months)
- Between-group changes in FIB-4 between baseline and month 12(12 months)
- Between-group changes in lean tissue mass between baseline and month 12(12 months)
- Between-group changes in liver fat in prespecified subgroups and in individuals with low respectively high dietary compliance based on dietary and lipogenic biomarkers changes between baseline and month 12(12 months)
- Between-group changes in blood lipids in prespecified subgroups and in individuals with low respectively high dietary compliance based on dietary and lipogenic biomarkers changes between baseline and month 12(12 months)
- Between-group changes in fasting plasma glucose between baseline and month 12(12 months)
- Between-group changes in HbA1c in prespecified subgroups and in individuals with low respectively high dietary compliance based on dietary and lipogenic biomarkers changes between baseline and month 12(12 months)
- Between-group changes in diastolic blood pressure between baseline and month 12(12 months)
- Between-group changes in plasma lipids (total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol, apoB and apoA1) between baseline and month 12(12 months)
- Between-group values in FMD at month 12(12 months)
研究者
研究点 (2)
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