Development of a Dietary Intervention Model Based on Genetic Data as an Implementation of a Healthy Lifestyle in the Management of Systemic Lupus Erythematosus Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Systemic Lupus Erythematosus (SLE) Disease Activity
研究概览
简要总结
The goal of this clinical trial is to learn if dietary intervention based on genetic data benefits in the management of systemic lupus erythematosus patients. It will also learn about the safety of this intervention. The main questions it aims to answer are:
- What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on disease activity?
- What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on quality of life Researchers would compare dietary intervention based on genetic data to a no intervention to see if dietary intervention based on genetic data improves disease activity and quality of life of SLE patients.
Participants will:
- Be checked for genetic test (HLA DQ2 and DQ8) as screening
- Be randomized to dietary intervention group or control group if has HLA DQ2 or DQ8 positive from screening
- Visit the clinic once every month for checkups and lab test if were randomized to dietary intervention group or control group
- Do food record as instructed if were randomized to dietary intervention group or control group
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with systemic lupus erythematosus (SLE) diagnosed according to the 2019 EULAR/ACR criteria, registered as patients at RSCM.
- •Age above 18 years
排除标准
- •Presence of active infection.
- •Refusal to participate in the study.
- •Breastfeeding.
- •Already on a specific autoimmune-related diet.
- •Patients with severe medical conditions (active cancer, stage V chronic kidney disease, or acute heart failure).
- •Patients taking corticosteroids equivalent to more than 20 mg/dL prednisone
研究组 & 干预措施
Dietary intervention based on genetic data
Dietary intervention with low gluten diet for systemic lupus patients with HLA-DQ2 or HLA-DQ8 positive
干预措施: Low gluten diet (Other)
Control group
Usual diet for systemic lupus erythematosus patients with HLA-DQ2 or DQ8 positive
结局指标
主要结局
Systemic Lupus Erythematosus (SLE) Disease Activity
时间窗: baseline, 1 month after intervention and 3 months after intervention
Measurement of Systemic Lupus Erythematosus disease activity using The Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX SLEDAI). Minimal score is 0 and maximal score is 32. Score 0-1 indicate remission; 2-5 indicate mild disease activity; 6-9 indicate moderate disease activity; 10-13 indicate severe disease activity; and ≥14 indicate very severe disease activity
Lupus Quality of life
时间窗: baseline, 1 month after intervention and 3 months after intervention
Measurement of the Quality of Life (QOL) of Systemic Lupus Erythematosus patient using the LupusQOL, a disease-specific, 34-item instrument that assesses eight domains: physical health pain, planning, intimate relationship, emotional health, burden to others, body image, and fatigue. Each item uses a 5-point Likert scale (0-4), with domain scores calculated by averaging item responses within each domain, dividing by four, and multiplying by 100 to yield scores ranging from 0 (worst) to 100 (best QoL)
次要结局
- Sleep quality(baseline, 1 month after intervention, and 3 months after intervention)
- Fatigue score(baseline, 1 month after intervention, and 3 months after intervention)
- Physical activity(baseline, 1 month after intervention, and 3 months after intervention)
- Anxiety and depression(baseline, 1 month after intervention, and 3 months after intervention)
研究者
Dr. dr. Alvina Widhani, Sp.PD, KAI
Associate Professor
Indonesia University