Blood Cell and Blood Factor Study in Metabolic Diseases
Compares blood cells and circulating factors in adults with metabolic disease and healthy adults.
Plain-language title generated from the registry record
Registry title: Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
Key facts
- Where
- Dresden, GermanySee the site
Where in Germany
- University Study Center for Metabolic DiseasesDresden, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Technische Universität Dresden
- Trial code
- NCT06396871
- Record updated
- 2 May 2024
- Original description
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:Read full original descriptionShow less
Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
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
Inclusion: Age > 18 years old; Additional inclusion criteria for case groups:; High risk group for significant liver fibrosis; FIB-4 score ≥ 1.3 AND 2. 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; Diabetes 1. HbA1c ≥ 6.5% OR/AND 2. Fasting Glucose > 126 mg/dl OR/AND 3. 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 1. 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.
Exclusion: Chronic alcohol or drug abuse; 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; Diabetes mellitus Typ 1; Transfusion of blood or major bleeding in the last six months; 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.); Severe psychic disorders; Have any medical condition unsuitable for inclusion in the study, in the opinion of the investigator; Additional exclusion criteria for MRI:; Artificial heart valve; 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; Anaemia with haemoglobin < 9,0 g/dl; 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; BMI < 18.5 kg/m2; Pregnancy or breastfeeding; Inability to follow the study protocol; Pacemaker; Metal prosthesis; Implanted magnetic metal parts; Spirals; Fixed metal dental braces; Acupuncture needle; Insulin pumps; By MRI > 3 Tesla: Tattoos, permanent eyeliner; Subject dimensions not allowing the performance of MRI.