Circulating Levels of Irisin in Healthy Young Subjects

NCT ID: NCT01986530

Last Updated: 2015-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-01-31

Brief Summary

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Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the role of circulating irisin in healthy individuals in correlation with lean and fat body mass. Furthermore, the circadian and seasonal variation of irisin is largely unknown.

Detailed Description

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The main aims of this prospective study will be to investigate: 1) circulating irisin levels in healthy, young men and women according to their lean and fat mass; 2) the circadian variations of irisin levels; 3) the seasonal variations of irisin levels.

Conditions

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Healthy Subjects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy individuals

Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece.

No interventions assigned to this group

Boost Subgroup

After an overnight fast, 40 participants will be provided a standardized mixed meal in two different quantities (125 ml, n=20 and 250 ml, n=20) and blood samples will be obtained before as well as 30 min after mixed meal ingestion

Boost

Intervention Type DIETARY_SUPPLEMENT

After an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion

Aerobic exercise

After an overnight fast, 20 participants will be subjected to aerobic exercise for 30 min and blood samples will be obtained at baseline and at 30 min

Aerobic exercise

Intervention Type OTHER

After an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise

Circadian variation Subgroup

20 of the participants will be hospitalized and closely monitored for 24 hours. A catheter will be inserted in a vein and blood samples will be obtained every 3 hours through the 24-hour period.

No interventions assigned to this group

Seasonal variation Subgroup

20 of the participants will be monitored for one year and blood samples will be obtained every 3 months (at the middle of month January - April - July - October). Subjects will be instructed to maintain their normal exercise routine and dietary habits.

No interventions assigned to this group

Interventions

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Boost

After an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion

Intervention Type DIETARY_SUPPLEMENT

Aerobic exercise

After an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Healthy volunteers

Exclusion Criteria: i) body mass index (BMI) above 30 or below 20 kg/m2; ii) diseases that could affect muscle or fat homeostasis; iii) medications that could affect muscle or fat homeostasis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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424 General Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Athanasios D. Anastasilakis

Consultant of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athanasios D Anastasilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

424 General Military Hospital

Locations

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424 General Military Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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Polyzos SA, Kountouras J, Anastasilakis AD, Geladari EV, Mantzoros CS. Irisin in patients with nonalcoholic fatty liver disease. Metabolism. 2014 Feb;63(2):207-17. doi: 10.1016/j.metabol.2013.09.013. Epub 2013 Oct 18.

Reference Type BACKGROUND
PMID: 24140091 (View on PubMed)

Vamvini MT, Aronis KN, Panagiotou G, Huh JY, Chamberland JP, Brinkoetter MT, Petrou M, Christophi CA, Kales SN, Christiani DC, Mantzoros CS. Irisin mRNA and circulating levels in relation to other myokines in healthy and morbidly obese humans. Eur J Endocrinol. 2013 Oct 21;169(6):829-34. doi: 10.1530/EJE-13-0276. Print 2013 Dec.

Reference Type BACKGROUND
PMID: 24062354 (View on PubMed)

Polyzos SA, Kountouras J, Shields K, Mantzoros CS. Irisin: a renaissance in metabolism? Metabolism. 2013 Aug;62(8):1037-44. doi: 10.1016/j.metabol.2013.04.008. Epub 2013 May 10. No abstract available.

Reference Type BACKGROUND
PMID: 23664085 (View on PubMed)

Huh JY, Panagiotou G, Mougios V, Brinkoetter M, Vamvini MT, Schneider BE, Mantzoros CS. FNDC5 and irisin in humans: I. Predictors of circulating concentrations in serum and plasma and II. mRNA expression and circulating concentrations in response to weight loss and exercise. Metabolism. 2012 Dec;61(12):1725-38. doi: 10.1016/j.metabol.2012.09.002. Epub 2012 Sep 25.

Reference Type BACKGROUND
PMID: 23018146 (View on PubMed)

Anastasilakis AD, Polyzos SA, Saridakis ZG, Kynigopoulos G, Skouvaklidou EC, Molyvas D, Vasiloglou MF, Apostolou A, Karagiozoglou-Lampoudi T, Siopi A, Mougios V, Chatzistavridis P, Panagiotou G, Filippaios A, Delaroudis S, Mantzoros CS. Circulating irisin in healthy, young individuals: day-night rhythm, effects of food intake and exercise, and associations with gender, physical activity, diet, and body composition. J Clin Endocrinol Metab. 2014 Sep;99(9):3247-55. doi: 10.1210/jc.2014-1367. Epub 2014 Jun 10.

Reference Type DERIVED
PMID: 24915120 (View on PubMed)

Other Identifiers

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424-IRIS

Identifier Type: OTHER

Identifier Source: secondary_id

SSAS-1-MANTZ

Identifier Type: -

Identifier Source: org_study_id

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