DiANa Project: Uncovering the Relationship Between MircroRNA Expression, Gut Microbiota and Prognosis in Patients with Anorexia Nervosa.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change of microRNA profile from baseline to week 12 and week 24
研究概览
简要总结
The goal of this study is to perform a comprehensive analysis of varied health markers and analyze the impact of lifestyle interventions on the prognosis of anorexia nervosa (AN) patients. In addition, this study aims to determine if biomarker analysis can be used as clinical outcomes for disease prognosis long-term and support individualized treatment strategies in female patients with AN during the post-hospitalization phase.
The main questions it aims to answer are:
- What are the miRs and microbiota profiles associated with AN, and how are they linked to other clinical markers?
- How does a lifestyle intervention (exercise with nutritional support) affect biomarkers and clinical markers during the first three months after hospitalization?
- What are the dynamics and associations of biomarkers, including gut microbiota, and how do they relate to critical events during the six months after hospitalization?
- What is the perceived effect of participating in a healthy lifestyle program for patients, families, and professionals involved in the care of these patients?
Participants will:
- Undergo analysis of biomarkers and gut microbiota associated with AN.
- Participate in a lifestyle intervention program involving exercise during the first three months post-hospitalization.
- Provide samples for biomarker and gut microbiota mapping over a six-month period.
- Share feedback on their perceived experience in the lifestyle program through interviews or surveys.
Researchers will compare biomarker and gut microbiota and the effects of the intervention to determine if a lifestyle exercise intervention can lead to better outcomes, and analyze its potential to individualized care strategies.
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
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A) Patients:
- •Patients with a diagnosis of AN (any subtype)
- •BMI >14kg/m2
- •Under treatment at the Regional Eating Disorders Unit at the Area IV and V of the Principality of Asturias
- •After acute treatment (total or partial hospitalization or other acute treatment regime following the recommendation of the medical team)
- •B) Healthy Controls:
- •Meet the physical activity recommendations of the World Health Organization for the age group and sex.
排除标准
- •A) Patients:
- •Contraindications to perform the evaluations proposed in this project
- •Unmanaged dysfunctional or compulsive exercise
- •Other criteria that, in the opinion of the medical team, prioritize the patient's health (i.e., psychological instability, substance abuse) .
- •B) Healthy Controls:
- •Suffer from metabolic, pulmonary or cardiovascular disease
- •Suffer from serious organic disease
- •Taking prescribed medications while participating in the project
- •Have contraindications to perform the proposed assessments or intervention.
研究组 & 干预措施
AN-Intervention
Patient enrolled in the exercise intervention group
干预措施: Progressive Resistance Exercise (Behavioral)
AN-Control
Patient enrolled in the non-exercise group
H-Control
Healthy controls in the non-exercise group
结局指标
主要结局
Change of microRNA profile from baseline to week 12 and week 24
时间窗: Baseline, week 12 and week 24
microRNAs are epigenetic markers that are sensitive to lifestyle interventions. A possible change is an improved profile after exercise intervention. microRNAs are measured in reads per million
Change of gut microbiota profile from baseline to week 12 and week 24
时间窗: Baseline, week 12 and week 24
Gut microbiota is a group of bacteria that are sensitive to lifestyle interventions, stress and other environmental factors. A possible change is an improved profile after exercise intervention. Microbiota is measured in reads per million
Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24
时间窗: Baseline, week 12 and week 24
The EDE-Q provides a global score and four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) derived from a 7-point Likert scale, where 0 indicates no symptoms or concerns and 6 indicates the most severe symptoms or concerns. Higher scores represent greater severity of eating disorder pathology
Change of muscle strength from baseline to week 12 and week 24
时间窗: Baseline, week 12 and week 24
Muscle strength is a physical fitness marker that is sensitive to lifestyle interventions. A possible change is an improved muscle strength after exercise intervention. Strength is measured in kilograms, Newtons, Watts, velocity (meters/second) or time (seconds).
Change of muscle content from baseline to week 12 and week 24
时间窗: Baseline, week 12 and week 24
Muscle content is a marker of health that is sensitive to lifestyle interventions and is measured with BioImpedance Analysis. A possible change is an improved muscle content after exercise intervention. Muscle content is measured in Kilograms or squared centimeters.
次要结局
- Change of the anthropometric profile from baseline to week 12 and week 24(Baseline, week 12 and week 24)
- Change of fat content from baseline to week 12 and week 24(Baseline, week 12 and week 24)
- Change of functional capacity from baseline to week 12 and week 24(Baseline, week 12 and week 24)
- Change of Physical Activity Levels from baseline to week 12 and week 24(Baseline, week 12 and week 24)
- Change of Beck Depression Inventory 2 (BDI-2) from baseline to week 12 and week 24(Baseline, week 12 and week 24)
- Change of Brief Symptom Inventory (BSI) scores from baseline to week 12 and week 24(Baseline, week 12 and week 24)
- Change of The Short Form-36 Health Survey (SF-36) scores from baseline to week 12 and week 24(Baseline, week 12 and week 24)