NCT06396871招募中不适用
Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Qualitative differences in platelets
研究概览
简要总结
The goal of this cross-sectional observational study is to to perform a thorough characterization of the quantitative and qualitative differences in peripheral blood cells, and circulating factors (proteins, metabolites, lipids, extracellular vesicles) in different stages of several metabolic diseases (diabetes, obesity, non-alcoholic fatty liver disease) that share common pathophysiological mechanisms and in comparison with adult healthy controls. The main question[s] it aims to answer are:
- Which are the quantitative (number and concentration) and qualtitative (characteristics, functional assays) differences in platelets in patients with metabolic diseases vs subjects without metabolic diseases
- Which are the quantitative (number and concentration) and qualtitative (characteristics, functional assays) differences in leucocytes or circulating molecules in patients with metabolic diseases vs subjects without metabolic diseases
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Age > 18 years old
- •Additional inclusion criteria for case groups:
- •High risk group for significant liver fibrosis
- •FIB-4 score ≥ 1.3 AND
- •Fibroscan measurement ≥ 8kPa
- •Steatotic Liver Disease group
- •Diagnosis of steatosis in ultrasound AND CAP > 275 dB/m
- •Prediabetes
- •HbA1c >5.7 AND <6.5% OR/AND
- •Fasting Glucose 100-125 mg/dl OR/AND
- •Glucose at 120 min of OGTT between 140-200 mg/dl
- •HbA1c ≥ 6.5% OR/AND
- •Fasting Glucose > 126 mg/dl OR/AND
- •Glucose at 120 min of OGTT > 200 mg/dl
- •If a subject does not fulfil the additional criteria for participating in a case group, then he/she will be included in the respective control group which will be:
- •A#) Low risk for significant liver fibrosis
- •Fibroscan measurements < 8kPa B#) No steatosis group
- •No steatosis in liver ultrasound AND CAP ≤ 275 dB/m C#) Normal glucose tolerance test group
- •HbA1c < 5.7% AND
- •Fasting glucose < 100 mg/dl AND
- •Glucose at 120 min of OGTT <140 mg/dl
排除标准
- •Diabetes mellitus Typ 1
- •BMI < 18.5 kg/m2
- •Transfusion of blood or major bleeding in the last six months
- •Anaemia with haemoglobin < 9,0 g/dl
- •Chronic alcohol or drug abuse
- •Presence of any acute or chronic liver disease apart from non-alcoholic fatty liver disease (i.e. viral, autoimmune or alcoholic hepatitis, haemochromatosis, Morbus Wilson etc.)
- •Systemic infections (CRP > 1 mg/dl)
- •Medications that affect blood glucose levels (e.g. antidiabetics [except from the subjects forming the diabetes group], steroids) in the last six months
- •Medications that affect coagulation (e.g. anticoagulants and antiplatelet agents) in the last six months
- •Medications that affect immune function (e.g. immunosuppressive drugs) in the last six months
- •Pregnancy or breastfeeding
- •Severe psychic disorders
- •Inability to follow the study protocol
- •Have any medical condition unsuitable for inclusion in the study, in the opinion of the investigator
- •Additional exclusion criteria for MRI:
- •Artificial heart valve
- •Metal prosthesis
- •Implanted magnetic metal parts
- •Fixed metal dental braces
- •Acupuncture needle
- •Insulin pumps
- •By MRI > 3 Tesla: Tattoos, permanent eyeliner
- •Claustrophobia or any other condition, such as psychiatric disorder, that in the opinion of the investigator may prevent the participant from following and completing the protocol
- •Subject dimensions not allowing the performance of MRI
结局指标
主要结局
Qualitative differences in platelets
时间窗: 1 day
% of Platelet aggregation
Quantitative differences in platelets
时间窗: 1 day
Platelet count in GPt/L
次要结局
- Qualitative differences in neutrophils in NETosis(1 day)
- Quantitative differences in neutrophils(1 day)
- Quantitative differences in leukocytes(1 day)
- Quantitative differences in lymphocytes(1 day)
- Qualitative differences in neutrophils in phagocytosis(1 day)
- Quantitative differences in monocytes(1 day)
- Quantitative differences in Interleukin-8(1 day)
- Qualitative differences in monocytes(1 day)
- Quantitative differences in Interleukin-6(1 day)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Immunoprofilling of Peripheral Blood Mononuclear Cells in Children With Attention Deficit/Hyperactivity DisorderADHDImmune SystemClinical SyndromeNCT06109337First Affiliated Hospital of Zhejiang University100
进行中（未招募）
不适用
Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers)Carcinoma, Renal CellCarcinoma, UrothelialNCT02978118Duke University67
招募中
不适用
Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain TumorsBrain Tumor, PrimaryBrain Tumor - MetastaticNCT05831631Pietro Mortini, MD, Prof.200
已完成
不适用
Selecting Specific Bio-markers and Researching Mechanisms of Immune Regulation From Inhalation Injury and Traumatic Lung Injury Based on Single Cell Sequencing TechnologyTraumatic Lung InjuryInhalation InjuryNCT05718830Changhai Hospital21
已完成
不适用
A Comparative Study of Two Kinds of Hemodialysis FiltersUremiaNCT05899283Chinese PLA General Hospital10