Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome
PROG-FAM
1 other identifier
observational
80
1 country
1
Brief Summary
The main objective of the study is to assess the serum levels of progranulin and FAM19A5 protein in adults with metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
July 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedAugust 14, 2020
August 1, 2020
11 months
June 15, 2020
August 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progranulin
Concentration of progranulin in serum
Measured at baseline
FAM19A5 Protein
Concentration of FAM19A5 protein in serum
Measured at baseline
Secondary Outcomes (32)
Progranulin genes
Measured at baseline
FAM19A5 protein genes
Measured at baseline
Leptin
Measured at baseline
Vascular endothelial growth factor (VGEF)
Measured at baseline
Insulin
Measured at baseline
- +27 more secondary outcomes
Study Arms (2)
Group A - study group - patients with metabolic syndrome
Patients with metabolic syndrome will be included. Procedures: 1. blood sample collection 2. hair sample collection 3. urine sample collection 4. body composition analysis 5. questionnaires 6. blood pressure, pulse and blood oxygen saturation measurement
Group B - control group - patients without metabolic syndrome
Patients without metabolic syndrome will be included. 1. blood sample collection 2. hair sample collection 3. urine sample collection 4. body composition analysis 5. questionnaires 6. blood pressure, pulse and blood oxygen saturation measurement
Interventions
Fasting blood sample will be collected from forearm vein. In the sample the concentration of: progranulin and serum FAM19A5 protein, leptin, VEGF, insulin, neopterin, adropin and selected cytokines, adipokines, myokines and chemokines, total cholesterol, low-density lipoproteins, high-density lipoproteins, triglycerides and glucose will be determined. Whole blood sample will be secured to isolate genetic material, detect and examine progranulin and FAM19A5 genes, and genes associated with the development of metabolic syndrome and with the body's mineral management. Serum mineral analysis will be performed.
Hair sample collection will be performed. Hair mineral analysis will be performed.
Urine sample collection will be performed. Urine mineral analysis will be performed.
Body composition analysis with the use of electric bioimpedance will be performed.
Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.
Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.
Eligibility Criteria
40 people (women and men) with metabolic syndrome (study group) and 40 people (women and men) without metabolic syndrome (control group).
You may qualify if:
- written and informed consent of the participant to participate in the study;
- age 18-99;
- meeting at least three of the following five metabolic syndrome criteria:
- waist circumference ≥80 cm in women and ≥94 cm in men;
- serum triglycerides\> 150 mg / dl (1.7 mmol / l) or treatment of hypertriglyceridemia;
- HDL serum concentration \<50 mg / dl (1.3 mmol / l) - in women and \<40 mg / dl (1.0 mmol / l) - in men or treatment of this lipid disorder;
- systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg, or treatment of previously diagnosed hypertension;
- fasting plasma glucose ≥100 mg / dl (5.6 mmol / l) or pharmacological treatment of type 2 diabetes.
You may not qualify if:
- secondary form obesity,
- substitution of progranulin or / and FAM19A5 protein,
- weight reduction above 5% of baseline body weight in the last 3 months preceding recruitment,
- liposuction and / or other fat reduction treatments,
- pacemaker, cardioverter / defibrillator,
- condition after stroke,
- Alzheimer's disease,
- fronto-temporal dementia,
- occurrence of other neurodegenerative diseases,
- occurrence of significant neurological disorders,
- occurrence of inflammatory autoimmune diseases,
- lysosomal storage diseases,
- clinically significant abnormal liver, kidney or thyroid function;
- acute or clinically significant inflammatory process in the respiratory, digestive, genitourinary tracts,
- connective tissue diseases or arthritis;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
Poznan, Wielkopolska, 60-569, Poland
Biospecimen
Samples of blood, hair and urine will be collected. From whole-blood samples of serum and plasma will be determined. From whole-blood genetic material will be isolated. Samples of serum, plasma, whole-blood, urine and serum will be signed with patient's unique code preventing patient's data identification. Only study team will have access to samples.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Damian Skrypnik, MD; PhD
Poznan University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 30, 2020
Study Start
July 3, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
August 14, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share