Study of Metabolic Pathways for the Identification of Biomarkers in Hashimoto's Thyroiditis and Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Differential levels of urinary organic acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS
研究概览
简要总结
Hashimoto's disease (HT) and psoriasis (PsO) have a significant impact on patient's quality of everyday life, and early diagnosis is critical for the symptoms management and prognosis. There is evidence that HT and PsO share common metabolic pathways that relate to their pathogenesis, and are affected by dietary and lifestyle factors. Previous studies have identified potential metabolic biomarkers, although the small number of studies hamper their validation. Of note, most studies are not longitudinal thus do not capture the metabolic fluctuations in response to disease progression or dietary changes. Thus, the purpose of this study is to identify metabolic biomarkers of HT and PsO and study the role of epigenetic factors (diet and lifestyle) on the involved metabolic pathways . In addition, a comparative analysis of the disease-related quality of life (QoL) will be performed in relation to dietary changes to unravel possible links between the QoL and the associated metabolic pathways in HT and PsO.
详细描述
Patients with Hashimoto's thyroiditis (HT), patients with psoriasis (PsO), and healthy individuals aged 18-60 will be recruited and assessed according to inclusion/exclusion criteria. Eligible participants will be randomized to two groups. The intervention group will receive a combinational nutraceuticals plan for 6 months as part of a Mediterranean diet and the control group will follow usual diet. Data will be collected at baseline and at the end of the study including levels of organic and fatty acids, lifestyle and anthropometric measurements, adherence to Mediterranean diet through the Mediterranean Diet Score (MDS) and disease-specific quality of life through the Thyroid Patient Report Outcome (THYPRO) and the Dermatology Life Quality Index (DLQI) questionnaires for the HT and the PsO group respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •malignant or congenital goiter
- •thyroidectomy
结局指标
主要结局
Differential levels of urinary organic acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS
时间窗: Baseline
Levels of organic acids will be quantified in the urine of patients with Hashimoto's diseases and psoriasis and the healthy group at baseline. Concentrations will be calculated in relation to creatinine (mmol/mol Crea) using Gas Chromatography-Mass Spectrometry (GC-MS). Comparisons will be made at organic acids concentrations between the HT, the PSO and the healthy group to determine disease-related differences
Differential levels of peripheral blood fatty acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS
时间窗: Baseline
Levels of total fatty acids will be quantified (μmol/l) in the peripheral blood of patients with Hashimoto's diseases and psoriasis and the healthy group at baseline using Gas Chromatography-Mass Spectrometry (GC-MS) Comparisons will be made at fatty acids concentrations between the HT, the PSO and the healthy group to determine disease-related differences
Change from baseline psoriasis-related quality of life at 6-months of intervention with nutraceuticals as assessed by the DLQI questionnaire
时间窗: 6 months
The Dermatology Life Quality Index (DLQI) will be completed by the HT group and the PSO group (both arms) at baseline and 6 months post intervention. DLQI score (0-30) after the intervention will be compared with baseline.
Change from baseline peripheral blood fatty acids levels after the 6-month intervention with nutraceuticals as assessed by GC-MS
时间窗: 6 months
Levels of total fatty acids will be quantified (μmol/l) in the peripheral blood of patients with Hashimoto's diseases and psoriasis and the healthy group after 6 months of intervention. Comparisons will be made at fatty acids concentrations between baseline levels and post 6 months of treatment in the HT, the PSO and the healthy group to determine intervention-related differences
Change from baseline Mediterranean diet adherence at 6 months of intervention with nutraceuticals as assessed by the MDS questionnaire
时间窗: 6 months
The Mediterranean Diet Score (MDS) questionnaire will be collected for all participants (both arms) at baseline and 6 months post the intervention. MDS (0-17) after the intervention will be compared with baseline.
Change from baseline urinary organic acids levels after 6-month intervention with nutraceuticals as assessed by GC-MS
时间窗: 6 months
Levels of organic acids will be quantified in the urine of patients with Hashimoto's diseases and psoriasis and the healthy group after 6 months of intervention. Concentrations will be calculated in relation to creatinine (mmol/mol Crea). Comparisons will be made at organic acids concentrations between baseline levels and post 6 months treatment in the HT, the PSO and the healthy group to determine intervention-related differences
Change from baseline thyroid disease-related quality of life at 6-months of intervention with nutraceuticals as assessed by the THYPRO questionnaire
时间窗: 6 months
The Thyroid Patient Response Outcome (THYPRO) questionnaire will be completed by the HT group at baseline and 6 months post intervention (both arms). THYPRO score (0-100) after the intervention will be compared with baseline.
次要结局
- Change from baseline Body Mass Index at 6 months of intervention with nutraceuticals(6 months)
- Change from baseline alcohol consumption at 6 months of intervention with nutraceuticals(6 months)
- Change from baseline waist circumference at 6 months of intervention with nutraceuticals(6 months)
- Change from baseline physical activity at 6 months of intervention with nutraceuticals(6 months)
- Change from baseline smoking at 6 months of intervention with nutraceuticals(6 months)
研究者
Evangelia Sarandi
Biologist, MSc, PhD student
University of Crete