跳至主要内容
临床试验/NCT05530070
NCT05530070招募中不适用

Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

University of Pecs2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
190
试验地点
2
主要终点
Percent body fat

研究概览

简要总结

This investigation examines the most important cardiovascular risk factors (e.g., metabolic parameters, body composition) and their changes in coeliac disease. The series of studies allow to assess body composition and cardiovascular risk-related metabolic parameters of newly diagnosed and treated coeliac patients in their complexity and to test if they change during therapy. The interventional part of the investigation aims to answer the question if a dietary intervention mitigates the unfavorable effects of unbalanced diet.

详细描述

The global prevalence of coeliac disease (CD) is increasing, which contributes to the disease's significant public health care burden. Body composition and metabolic parameters of coeliac patients differ from the healthy population. Patients with non-classical CD are not necessarily lean; they usually have normal body weight but can be even overweight or obese. In coeliac patients, bodyweight tends to elevate, whereas the body composition changes unfavourably during a gluten-free diet (GFD). A reason for gaining weight is the improvement of malabsorption but an important contributor is the nutrient composition of the GFD, which generally has a high calorie density with high carbohydrate and fat content while being low in fibre. While terminating or mitigating the inflammatory process - if done without adequate dietary control - a GFD can readily lead to weight gain and unfavourably metabolic consequences (e.g., dyslipidemia, fatty liver disease, insulin resistance). The result can be an increase in cardiovascular risk in CD patients with a normal or high body weight at diagnosis. However, limited information is available on the cardiovascular (CV) risk in coeliac disease, and the data are controversial. This study examines the body composition and cardiovascular risk-related metabolic parameters at the diagnosis and on a gluten-free diet in a Hungarian cohort of CD patients. The randomised controlled trial (RCT) investigates the effect of structured, repeated, group-based dietary education on the examined metabolic parameters and body composition.

This study aims to draw attention to a new aspect of the management of CD patients: from a metabolic and cardiovascular point of view. Findings will help to identify which parameters are beneficial to optimize and re-assess during follow-up in CD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Due to the nature of the study, the blinding of the participants is not possible. The blinding of the physicians, data managers and statisticians will be secured.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Chronic conditions:
  • Estimated glomerular filtration rate calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is <60mL/min/1.73m2 (CKD3 or more severe kidney failure).
  • Liver cirrhosis in Child-Pugh class B-C.
  • Heart failure (New York Heart Association (NYHA) III-IV).
  • Active malignant diseases.
  • Any acute diseases or acute deterioration of underlying chronic conditions.
  • Diseases that may be associated with clinically relevant malabsorption.
  • Refractory CD.
  • Pregnancy, lactation.
  • Patients unable to understand the essentials of the informed consent.
  • Lack of consent or withdrawal of consent.

结局指标

主要结局

Percent body fat

时间窗: 1 year

Percent body fat in percentage measured by an InBody 770 body composition analyzer.

次要结局

  • Waist circumference(1 year)
  • Blood pressure(1 year)
  • Fatty liver disease(1 year)
  • Cardiovascular risk assessment(1 year)
  • Coeliac disease-related symptoms(1 year)
  • Coeliac disease-specific quality of life(1 year)
  • Disease activity(1 year)
  • Sarcopenia(1 year)
  • Triglyceride level(1 year)
  • Cholesterol level(1 year)
  • Fasting glucose level(1 year)
  • Fasting insulin level(1 year)
  • Haemoglobin (Hb) A1c level(1 year)
  • Homeostasis Model Assessment (HOMA) index(1 year)
  • Bilirubin level(1 year)
  • Uric acid level(1 year)
  • Urea level(1 year)
  • Creatinine level(1 year)
  • Sodium level(1 year)
  • Potassium level(1 year)
  • Folic acid level(1 year)
  • Calcium level(1 year)
  • Vitamin D(1 year)
  • Vitamin B12(1 year)
  • Iron level(1 year)
  • Ferritin level(1 year)
  • Transferrin level(1 year)
  • Transferrin saturation(1 year)
  • International Normalized Ratio (INR)(1 year)
  • Aspartate aminotransferase level(1 year)
  • Alanine aminotransferase level(1 year)
  • Fibrosis-4 (FIB-4) Index(1 year)
  • Total protein level(1 year)
  • Albumin level(1 year)
  • Immunoglobulins(1 year)
  • High-sensitivity C-reactive protein (hs-CRP) level(1 year)
  • Fibrinogen level(1 year)
  • Blood counts(1 year)
  • Homocysteine levels(1 year)
  • Interleukin-6 levels(1 year)
  • Leptin levels(1 year)
  • Ghrelin levels(1 year)
  • Adiponectin levels(1 year)
  • Galectin-3 levels(1 year)
  • Dietary interview(1 year)
  • Celiac Disease Adherence Test(1 year)
  • Coeliac-specific antibodies(1 year)
  • Urine gluten immunogenic peptide(1 year)
  • Diet composition(1 year)
  • Body height(1 year)
  • Body weight(1 year)
  • Body mass index(1 year)
  • Body fat mass(1 year)
  • Skeletal muscle mass(1 year)
  • Visceral fat area(1 year)
  • Total body water(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Cardiovascular Risk Factors in Coeliac Disease: a... | 临床试验