Circulating Levels of Irisin in Healthy Young Subjects

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT01986530
• Lead Sponsor: 424 General Military Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-09
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-18
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Irisin postprandial	1 day	A sub-population of 40 participants of the cohort will receive a standardized meal (Boost) in two different quantities (20 participants will receive 125 ml and 20 participants 250 ml). Serum irisin levels will be measured at baseline and 30 min postprandial.
irisin circadian variation	1 day	20 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
Irisin	1 day	After a standardized dinner and an overnight fast, a blood sample will be obtained the next morning.
Irisin after excercise	1 day	A sub-population of 20 participants of the cohort will be subjected to 30 min of aerobic exercise. Serum irisin levels will be measured at baseline and at 30 min.
irisin seasonal variation	12 months	20 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). At the same intervals physical examination and BMI calculation will be conducted. Subjects will be instructed to maintain their normal exercise routine and dietary habits.

Secondary Outcome Measures

Name	Time	Method
Irisin associates	1 day	After a standardized dinner and an overnight fast, a blood sample for adiponectin and leptin will be obtained the next morning, and body composition (total body fat mass and bone-free lean mass) will be assessed by BIA. Participants will also be asked to complete a validated questionnaire assessing their diet and exercise habits. Correlations between serum irisin levels and the above parameters will be examined
serum adipokines	1 day	After a standardized dinner and an overnight fast, a blood sample for adiponectin and leptin will be obtained the next morning.

Trial Locations

Locations (1)

424 General Military Hospital; 🇬🇷 Thessaloniki, Greece