Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glycemic variability
研究概览
简要总结
This study aims to understand how adipose tissue (fat) and the gut microbiota (the bacteria in the gut) may influence brain function and cognition. It has been observed that changes in adipose tissue in animals such as mice and Drosophila (a type of insect) affect memory and other brain functions. Additionally, it is believed that the gut microbiota also plays an important role in cognition.
This study will explore how gene expression in adipose tissue, blood metabolites, and the gut microbiota are related to cognitive function, such as memory and thinking, in individuals with and without obesity. The investigation will also assess whether these factors can predict changes in the brain over time and how they influence sleep, physical activity, and blood sugar regulation.
Advanced technologies will be used to analyze samples of tissue, blood, and microbiota, with the goal of identifying new mechanisms through which obesity affects the brain. This research may contribute to the development of new diagnostic and therapeutic strategies for cognitive problems in individuals with obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women >20 years old.
- •Scheduled for surgical intervention to extract adipose tissue.
- •Signed informed consent for study participation.
排除标准
- •Not meeting inclusion criteria.
- •Non-obesity-related systemic diseases (cancer, severe kidney/liver disease).
- •Systemic diseases with intrinsic inflammation (rheumatoid arthritis, Crohn's disease, asthma, chronic infections (HIV/tuberculosis)) or any type of infectious disease.
- •Pregnant/breastfeeding women.
- •Persons under legal/administrative restrictions.
- •Those with infection symptoms in the past month.
- •Use of antibiotics/antifungals/antivirals (previous 3 months).
- •Chronic steroidal/anti-inflammatory drug use.
- •Major psychiatric history.
- •Excessive alcohol intake, acute or chronic (>40g/day (women), >80g/day (men)) or drug abuse.
- •Immunosuppressants treatment.
- •Participants with severe eating disorders.
- •Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
- •History of iron balance disorders (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
- •Creatinine greater than 1.2 and glomerular filtration rate below
- •Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer.
- •Heart disease classified as class III or IV, known ischemic cardiovascular disease.
- •Renal failure, history of kidney transplant, or current dialysis treatment.
- •Chronic constipation (bowel movement frequency ≥ 7 days) .
结局指标
主要结局
Glycemic variability
时间窗: 36 month
Mean and standard deviation of glucose measures in mg/dL using a CGM 10 days.
The glycaemic risk measured with the low blood glucose index (LBGI)
时间窗: 36 months
Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic.
The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)
时间窗: 36 months
The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)
时间窗: 36 months
measured in mg/dl
Minutes light sleep
时间窗: 36 months
Mean and standard deviation of minutes' light sleep measures by activity and sleep tracker device.
Minutes deep sleep
时间窗: 36 months
Mean and standard deviation of minutes' deep sleep measures by activity and sleep tracker device.
Minutes rapid eye movement (REM)
时间窗: 36 months
Mean and standard deviation of minutes REM measures by activity and sleep tracker device.
次要结局
- Audioverbal memory(36 months)
- Effect on gut microbiota(36 months)
- Visual memory(36 months)
- Depressive symptomatology(36 months)
- Impulsivity(36 months)
- Food Addiction(36 months)
- Behavioural inhibition(36 months)
- Behavioural activation(36 months)
- Inhibition(36 months)
- Phonemic verbal fluency(36 months)
- Visoconstructive function(36 months)
- Selective and alternating attention(36 months)
- Attention and working memory(36 months)
- Semantic verbal fluency(36 months)
- Facial recognition(36 months)
- Emotion recognition(36 months)
- Effect on brain structure(36 months)
- Binge eating disorder(36 months)
- Anxiety state(36 months)
- Glycosylated haemoglobin (HbA1c) value(36 months)
- Diffusion Tensor Imaging brain sequences(36 months)
- Brain iron accumulation(36 months)
- Resting-state functional brain sequences(36 months)
- Insulin resistance(36 months)
- Markers of chronic inflammation (C-reactive protein, IL-6, adiponectin and soluble, tumour necrosis factor-α receptor fractions)(36 months)
- The percentage of time in hyperglycaemia (glucose level above 250 mg/dl)(36 months)
- The percentage of time in hypoglycaemia (glucose level below 70mg/dl)(36 months)
- The percentage of time in glucose range (glucose level below 100 mg/dl)(36 months)
- The percentage of time in glucose range (glucose level between 126-139 mg/dl)(36 months)
- The percentage of time in glucose range (glucose level between 140-199 mg/dl)(36 months)
- The percentage of time in glucose range (glucose level above 200 mg/dl)(36 months)
- Burned calories(36 months)
- Steps Mean and standard deviation of steps measures by activity and sleep tracker device.(36 months)
- Distance Mean and standard deviation of distance measures by activity and sleep tracker device.(36 months)
- Minutes null activity(36 months)
- Minutes slight activity(36 months)
- Minutes mean activity(36 months)
- Minutes high activity(36 months)
- Calories(36 months)
- Minutes asleep(36 months)
- Minutes awake(36 months)
- Bed time Mean and standard deviation of bed time measures by activity and sleep tracker device.(36 months)
- Number time awake Mean and standard deviation of number time awake measures by activity and sleep(36 months)
研究者
José Manuel Fernández-Real
Principal investigator, clinical professor, section chief of Endocrinology and Nutrition Department of Josep Trueta University Hospital
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta