维生素D补充剂与网膜素-1基因多态性对糖尿病前期女性代谢因素和人体测量指标的相互作用：一项双盲随机对照试验的研究方案

The interaction of vitamin D supplementation with Omentin-1 gene polymorphism on metabolic factors and anthropometric indices in women with prediabetes: a study protocol for a double-blind randomized controlled trial.

作者信息

Molani-Gol Roghayeh, Rafraf Maryam, Asghari Jafarabadi Mohammad, Shanehbandi Dariush

机构信息

Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.

Nutrition Research Center, Department of Community Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Attarneishabori street, Daneshghah Avenue, Tabriz, Iran.

出版信息

BMC Complement Med Ther. 2025 Aug 6;25(1):299. doi: 10.1186/s12906-025-05034-2.

DOI:10.1186/s12906-025-05034-2

PMID:40770752

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12330007/

Abstract

BACKGROUND

Prediabetes is a public health problem, and its prevalence is increasing around the world. Providing an effective strategy to prevent the progression of prediabetes and, consequently, type-2 diabetes mellitus (T2DM) could be useful for global health. Research suggests that vitamin D might contribute to decreasing the risk of developing and progressing T2DM. Moreover, Val109Asp polymorphism is also reported to be associated with insulin resistance. Therefore, the primary aim of this trial is to investigate the interaction of vitamin D supplementation with gene polymorphism on metabolic factors and anthropometric indices in women with prediabetes.

METHODS/DESIGN: In this double-blind randomized controlled trial, prediabetic women ( = 204) aged 18–65 years that will be recognized based on FBS: 100–125 mg/dL or HbA1c: 5.7-6.4% will be invited to participate in this study. After obtaining informed consent, all participants’ blood samples will be achieved to determine the Omentin-1 polymorphism (Val109Asp) genotypes. Then the women will be randomized to the intervention ( = 24) or placebo ( = 24) groups (1:1) in each genotype of Omentin-1 polymorphism. In total, 144 women will be allocated to receive vitamin D (50000 IU) or a placebo (1:1) every two weeks for 12 weeks. Supplements will be provided to the participants at the beginning of the study and the end of each month and data will be collected at the baseline and after 12 weeks. Primary outcome measures are fasting glucose, insulin serum, and serum lipid profile levels, and secondary outcome measures include anthropometric parameters and dietary intakes.

DISCUSSION

The present trial will provide more required clinical evidence on the effects of vitamin D supplementation on glycemic control and insulin resistance by considering polymorphism genetic variation in prediabetic patients, which is relevant for preventing T2DM.

TRIAL REGISTRATION

IRCT20100408003664N26.

SUPPLEMENTARY INFORMATION

The online version contains supplementary material available at 10.1186/s12906-025-05034-2.

摘要

背景

糖尿病前期是一个公共卫生问题，其在全球的患病率正在上升。提供一种有效的策略来预防糖尿病前期的进展，进而预防2型糖尿病（T2DM），可能对全球健康有益。研究表明，维生素D可能有助于降低患T2DM和T2DM进展的风险。此外，据报道Val109Asp基因多态性也与胰岛素抵抗有关。因此，本试验的主要目的是研究补充维生素D与基因多态性对糖尿病前期女性代谢因子和人体测量指标的相互作用。

方法/设计：在这项双盲随机对照试验中，将邀请年龄在18 - 65岁、根据空腹血糖（FBS）：100 - 125mg/dL或糖化血红蛋白（HbA1c）：5.7 - 6.4%确诊为糖尿病前期的女性参与本研究。在获得知情同意后，将采集所有参与者的血样以确定网膜素-1多态性（Val109Asp）基因型。然后，根据网膜素-1多态性的每种基因型，将女性随机分为干预组（n = 24）或安慰剂组（n = 24）（1:1）。总共144名女性将被分配接受维生素D（50000 IU）或安慰剂（1:1），每两周一次，共12周。在研究开始时和每个月末向参与者提供补充剂，并在基线和12周后收集数据。主要结局指标是空腹血糖、胰岛素血清水平和血脂谱水平，次要结局指标包括人体测量参数和饮食摄入量。