Mitochondrial Oxygen Consumption and Substrate Utilisation In Vitro in Peripheral Blood Mononuclear Cells, and In Vivo on Muscle and Skin in Long COVID Patients and Convalescent Individuals: A Case-Control and Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Mitochondrial oxygen tension (mitoPO2) (mmHg/s)
研究概览
简要总结
Mitochondria are structures inside cells that are responsible for producing energy from nutrients through a series of steps, using oxygen. To have an idea of how well the mitochondria can produce energy, we can measure how much oxygen they use. The goal of this study is to:
- To compare the oxygen use between people with long COVID and people who completely recovered after COVID-19, using three techniques that measure the oxygen use in blood cells, on the skin and in the muscle
- To test how similar these three techniques are in measuring the oxygen used in the three different tissues
Participants will:
- Complete surveys,
- Wear an activity tracker (7 days),
- Undergo several non-invasive tests, and
- Donate a blood sample The study will take place in UZ Brussel hospital and will take 2 study visits, approximately 7 days apart.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with long COVID:
- •Inclusion criteria:
- •Long COVID diagnosis, based on the WHO definition;
- •Presence of long COVID symptoms for a minimum of 6 months.
- •History of confirmed or documented SARS-CoV-2 infection.
- •Adult (≥18 years of age).
- •Post-COVID-19 Functional Status Scale grade 2-4, while they had a grade 0 before the SARS-CoV-2 infection.
排除标准
- •Pre-existing chronic diseases potentially affecting the functional status scale.
- •Treatment with metabolism altering drugs.
- •> 10 standard units of alcohol (10 grams of alcohol/glass) per week.
- •Unable to understand oral and written instructions in Dutch, French or English.
- •Allergies to medical adhesive bandages.
- •Porphyria and other skin conditions aggravated by sunlight.
- •Convalescent individuals
- •Inclusion criteria:
- •History of confirmed or documented SARS-CoV-2 infection.
- •Complete recovery after the SARS-CoV-2 infection, no history of long COVID based on the WHO definition;
- •Post-COVID-19 Functional Status Scale [2] grade 0 both before the infection and currently.
- •Adult (≥18 years of age).
- •Exclusion criteria:
- •Pre-existing chronic non-communicable diseases (e.g. hypertension, chronic respiratory diseases, diabetes).
- •Treatment with metabolism altering drugs.
- •> 10 standard units of alcohol (10 grams of alcohol/glass) per week.
- •Unable to understand oral and written instructions in Dutch, French or English.
- •Allergies to medical adhesive bandages.
- •Porphyria and other skin conditions aggravated by sunlight.
研究组 & 干预措施
Individuals with long COVID
History of a confirmed or documented SARS-CoV-2 infection and long COVID according to the World Health Organisation's clinical case definition
Convalescent individuals
History of a confirmed or documented SARS-CoV-2 infection, complete recovery after the SARS-CoV-2 infection, no history of long COVID according to the World Health Organisation's clinical case definition
结局指标
主要结局
Mitochondrial oxygen tension (mitoPO2) (mmHg/s)
时间窗: Second study visit (approximately 7 days after the first study visit)
Cellular Oxygen Metabolism monitoring
Mitochondrial oxygen consumption (mitoVO2)
时间窗: Second study visit (minimally 7 days after the first study visit)
Cellular Oxygen Metabolism monitoring
Tissue Saturation Index (TSI)
时间窗: Second study visit (approximately 7 days after the first study visit)
Near-infrared spectroscopy
Basal Oxygen Consumption rate (pmol O2/min)
时间窗: Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study)
Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs)
次要结局
- Resting Energy Expenditure (kcal/kg body weight/day)(Second study visit (approximately 7 days after the first study visit))
- Respiratory Quotient(Second study visit (approximately 7 days after the first study visit))
- Basal Oxygen Consumption rate (pmol O2/min)(Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study))
- Maximal Oxygen Consumption rate (pmol O2/min)(Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study))
- Proportion of participants meeting the criteria for PEM(Second study visit (minimally 7 days after the first study visit))
- Physical fatigue(Second study visit (approximately 7 days after the first study visit))
- General fatigue(Second study visit (approximately 7 days after the first study visit))
- Mental fatigue(Second study visit (approximately 7 days after the first study visit))
- Reduced activities(Second study visit (approximately 7 days after the first study visit))
- Reduced motivation(Second study visit (approximately 7 days after the first study visit))
- Severity and impact of fatigue on daily life(Second study visit (approximately 7 days after the first study visit))
- Symptom burden (θ)(First study visit)
研究者
Elisabeth De Waele
Head of the Department of Clinical Nutrition, Co-director of Vitality Research Group
Universitair Ziekenhuis Brussel