Nutrition DisordersPROG-FAMNCT04451616
Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome
An observational study of Nutrition Disorders and Hypertension, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The main objective of the study is to assess the serum levels of progranulin and FAM19A5 protein in adults with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders, Hypertension, Dyslipidemias
- What is being tested?
- Blood sample collection, Hair sample collection and Urine sample collection
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jul 2020to 1 Jun 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 people (women and men) with metabolic syndrome (study group) and 40 people (women and men) without metabolic syndrome (control group).
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 20Show fewer
- 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;
- active cancer,
- addiction to alcohol or drugs;
- pregnancy or childbirth during recruitment or 3 months before recruitment;
- current lactation or lactation within 3 months before recruitment;
- and / or any other condition which, according to researchers, would cause that participation would not be in the patient's best interest or could limit the credibility of the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
Poznan, Wielkopolska, 60-569
Damian Skrypnik, MD, PhD, +48798394812, damian.skrypnik@gmail.com
Paweł Bogdański, Prof., +48502335001, pawelbogdanski73@gmail.com
About this study
Official title: Assessment of Progranulin and Chemokine-like Protein TAFA-5 (FAM19A5) Blood Levels in Adults With Metabolic Syndrome
The main objective of the study is to assess the serum levels of progranulin and FAM19A5 protein in adults with metabolic syndrome.
Read the detailed description
The study is planned to be conducted on 40 adults with metabolic syndrome. As a control, it is planned to recruit 40 adults without metabolic syndrome. From all participants fasting venous blood samples, urine samples and hair samples will be collected. Next, serum progranulin and serum FAM19A5 protein concentrations will be determined in both groups. Also, serum concentration of leptin, vascular endothelial growth factor (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. Serum, hair and urine mineral content will be determined. In whole blood genetic analyses will be performed in order to detect and examine progranulin and FAM19A5 genes, and genes associated with the development of metabolic syndrome and genes associated with the body's mineral metabolism. Also, body composition analysis, blood pressure measurement, pulse measurement, blood oxygen saturation measurement and nutritional interview will be performed.
- Conditions
- Nutrition Disorders, Hypertension, Dyslipidemias, Glucose Intolerance, Glucose Metabolism Disorders, Obesity
- Being tested
- Blood sample collection, Hair sample collection, Urine sample collection, Body composition analysis, Questionnaires
- Keywords
- Obesity, Hypertension, Dyslipidemia, Progranulin, FAM19A5, Adipokines, Metabolic syndrome
- Medical subject headings
- Nutrition Disorders, Hypertension, Dyslipidemias, Glucose Intolerance, Glucose Metabolism Disorders, Obesity, Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionDiagnostic test
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 collectionDiagnostic test
Hair sample collection will be performed. Hair mineral analysis will be performed.
Urine sample collectionDiagnostic test
Urine sample collection will be performed. Urine mineral analysis will be performed.
Body composition analysisDiagnostic test
Body composition analysis with the use of electric bioimpedance will be performed.
QuestionnairesDiagnostic test
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 measurementDiagnostic test
Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Blood sample collection; Diagnostic Test: Hair sample collection; Diagnostic Test: Urine sample collection; Diagnostic Test: Body composition analysis; Diagnostic Test: Questionnaires; Diagnostic Test: 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 Receives: Diagnostic Test: Blood sample collection; Diagnostic Test: Hair sample collection; Diagnostic Test: Urine sample collection; Diagnostic Test: Body composition analysis; Diagnostic Test: Questionnaires; Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progranulin
Concentration of progranulin in serum
Measured: Measured at baseline
FAM19A5 Protein
Concentration of FAM19A5 protein in serum
Measured: Measured at baseline
Secondary outcomes (32)
Progranulin genes
Detection and testing of progranulin genes
Measured: Measured at baseline
FAM19A5 protein genes
Detection and testing of FAM19A5 protein genes
Measured: Measured at baseline
Leptin
Concentration of leptin in serum
Measured: Measured at baseline
Vascular endothelial growth factor (VGEF)
Concentration of VGEF in serum
Measured: Measured at baseline
Insulin
Concentration of insulin in serum
Measured: Measured at baseline
Neopterin
Concentration of neopterin in serum
Measured: Measured at baseline
Adropin
Concentration of adropin in serum
Measured: Measured at baseline
Iron level in hair
The content of iron will be determined in hair (atomic absorption spectrometry)
Measured: Measured at baseline
Zinc level in hair
The content of zinc will be determined in hair (atomic absorption spectrometry)
Measured: Measured at baseline
Copper level in hair
The content of copper will be determined in hair (atomic absorption spectrometry)
Measured: Measured at baseline
Iron level in serum
The content of iron will be determined in serum (atomic absorption spectrometry)
Measured: Measured at baseline
Zinc level in serum
The content of zinc will be determined in serum (atomic absorption spectrometry)
Measured: Measured at baseline
Copper level in serum
The content of copper will be determined in serum (atomic absorption spectrometry)
Measured: Measured at baseline
Iron level in urine
The content of iron will be determined in urine (atomic absorption spectrometry)
Measured: Measured at baseline
Zinc level in urine
The content of zinc will be determined in urine (atomic absorption spectrometry)
Measured: Measured at baseline
Copper level in urine
The content of copper will be determined in urine (atomic absorption spectrometry)
Measured: Measured at baseline
Body mass (BM)
Body mass
Measured: Measured at baseline
Waist circumference (WC)
Waist circumference
Measured: Measured at baseline
Hip circumference
Hip circumference
Measured: Measured at baseline
Neck circumference
Neck circumference
Measured: Measured at baseline
Body fat content
Body fat content in bioimpedance
Measured: Measured at baseline
Muscle mass content
Muscle mass content in bioimpedance
Measured: Measured at baseline
Total water content
Total water content in bioimpedance
Measured: Measured at baseline
Systolic blood pressure
Measurement of systolic blood pressure
Measured: Measured at baseline
Diastolic blood pressure
Measurement of diastolic blood pressure
Measured: Measured at baseline
Pulse
Measurement of pulse
Measured: Measured at baseline
Blood oxygen level
Measurement of blood oxygen level- measured non-invasively with the use of oximeter
Measured: Measured at baseline
Total cholesterol (TCH)
Blood concentration of total cholesterol
Measured: Measured at baseline
Low density lipoprotein (LDL)
Blood concentration of low density lipoprotein (LDL)
Measured: Measured at baseline
High density lipoprotein (HDL)
Blood concentration of high density lipoprotein (HDL)
Measured: Measured at baseline
Triglycerides
Blood concentration of triglycerides
Measured: Measured at baseline
Glucose
Blood concentration of glucose
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start3 Jul 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damian Skrypnik, MD; PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451616
- Sponsor's protocol ID
- 353/20
- Acronym
- PROG-FAM
- Status last verified
- Aug 2020
- First submitted
- 15 Jun 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Progranulin and Chemokine-like Protein TAFA-5 (FAM19A5) Blood Levels in Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04451616
- Acronym / sponsor ID
- PROG-FAM / 353/20
- Conditions
- Nutrition Disorders, Hypertension, Dyslipidemias, Glucose Intolerance, Glucose Metabolism Disorders, Obesity
- Keywords
- Obesity, Hypertension, Dyslipidemia, Progranulin, FAM19A5, Adipokines, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to assess the serum levels of progranulin and FAM19A5 protein in adults with metabolic syndrome.
Detailed description
The study is planned to be conducted on 40 adults with metabolic syndrome. As a control, it is planned to recruit 40 adults without metabolic syndrome. From all participants fasting venous blood samples, urine samples and hair samples will be collected. Next, serum progranulin and serum FAM19A5 protein concentrations will be determined in both groups. Also, serum concentration of leptin, vascular endothelial growth factor (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. Serum, hair and urine mineral content will be determined. In whole blood genetic analyses will be performed in order to detect and examine progranulin and FAM19A5 genes, and genes associated with the development of metabolic syndrome and genes associated with the body's mineral metabolism. Also, body composition analysis, blood pressure measurement, pulse measurement, blood oxygen saturation measurement and nutritional interview will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - study group - patients with metabolic syndrome | – | Diagnostic Test: Blood sample collection, Diagnostic Test: Hair sample collection, Diagnostic Test: Urine sample collection, Diagnostic Test: Body composition analysis, Diagnostic Test: Questionnaires, Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurementPatients 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 | – | Diagnostic Test: Blood sample collection, Diagnostic Test: Hair sample collection, Diagnostic Test: Urine sample collection, Diagnostic Test: Body composition analysis, Diagnostic Test: Questionnaires, Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurementPatients 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 people (women and men) with metabolic syndrome (study group) and 40 people (women and men) without metabolic syndrome (control group).
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionFasting 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. | Diagnostic test | Group A - study group - patients with metabolic syndrome, Group B - control group - patients without metabolic syndrome |
| Hair sample collectionHair sample collection will be performed. Hair mineral analysis will be performed. | Diagnostic test | Group A - study group - patients with metabolic syndrome, Group B - control group - patients without metabolic syndrome |
| Urine sample collectionUrine sample collection will be performed. Urine mineral analysis will be performed. | Diagnostic test | Group A - study group - patients with metabolic syndrome, Group B - control group - patients without metabolic syndrome |
| Body composition analysisBody composition analysis with the use of electric bioimpedance will be performed. | Diagnostic test | Group A - study group - patients with metabolic syndrome, Group B - control group - patients without metabolic syndrome |
| QuestionnairesDietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed. | Diagnostic test | Group A - study group - patients with metabolic syndrome, Group B - control group - patients without metabolic syndrome |
| Blood pressure, pulse and blood oxygen saturation measurementBlood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed. | Diagnostic test | Group A - study group - patients with metabolic syndrome, Group B - control group - patients without metabolic syndrome |
Primary outcome
Progranulin
Time frame: Measured at baseline
Concentration of progranulin in serum
FAM19A5 Protein
Time frame: Measured at baseline
Concentration of FAM19A5 protein in serum
32 secondary outcomes
Progranulin genes
Time frame: Measured at baseline
FAM19A5 protein genes
Time frame: Measured at baseline
Leptin
Time frame: Measured at baseline
Vascular endothelial growth factor (VGEF)
Time frame: Measured at baseline
Insulin
Time frame: Measured at baseline
Neopterin
Time frame: Measured at baseline
Adropin
Time frame: Measured at baseline
Iron level in hair
Time frame: Measured at baseline
Zinc level in hair
Time frame: Measured at baseline
Copper level in hair
Time frame: Measured at baseline
Iron level in serum
Time frame: Measured at baseline
Zinc level in serum
Time frame: Measured at baseline
Copper level in serum
Time frame: Measured at baseline
Iron level in urine
Time frame: Measured at baseline
Zinc level in urine
Time frame: Measured at baseline
Copper level in urine
Time frame: Measured at baseline
Body mass (BM)
Time frame: Measured at baseline
Waist circumference (WC)
Time frame: Measured at baseline
Hip circumference
Time frame: Measured at baseline
Neck circumference
Time frame: Measured at baseline
Body fat content
Time frame: Measured at baseline
Muscle mass content
Time frame: Measured at baseline
Total water content
Time frame: Measured at baseline
Systolic blood pressure
Time frame: Measured at baseline
Diastolic blood pressure
Time frame: Measured at baseline
Pulse
Time frame: Measured at baseline
Blood oxygen level
Time frame: Measured at baseline
Total cholesterol (TCH)
Time frame: Measured at baseline
Low density lipoprotein (LDL)
Time frame: Measured at baseline
High density lipoprotein (HDL)
Time frame: Measured at baseline
Triglycerides
Time frame: Measured at baseline
Glucose
Time frame: Measured at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian Skrypnik, MD; PhD study chair
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders and Hypertension, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damian Skrypnik, MD, PhD (+48 618549742, damian.skrypnik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progranulin (time frame: Measured at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.