Circulating Levels of Irisin in Healthy Young Subjects (IRISSAS)
2015年1月20日 更新者：Athanasios D. Anastasilakis、424 General Military Hospital
Circulating Irisin in Healthy Young Men and Women and Correlation With Lean Body Mass, Fat Mass and Adipocytokines. Circadian and Seasonal Variation and the Effect of Food Intake and Exercise
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
122
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Thessaloniki、希腊、56429
- 424 General Military Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 25年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Healthy individuals
Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece.
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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
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After an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion
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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
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After an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise
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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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Irisin
大体时间：1 day
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After a standardized dinner and an overnight fast, a blood sample will be obtained the next morning.
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1 day
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irisin circadian variation
大体时间：1 day
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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
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1 day
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irisin seasonal variation
大体时间：12 months
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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.
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12 months
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Irisin postprandial
大体时间：1 day
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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.
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1 day
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Irisin after excercise
大体时间：1 day
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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.
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1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Irisin associates
大体时间：1 day
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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
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1 day
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serum adipokines
大体时间：1 day
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After a standardized dinner and an overnight fast, a blood sample for adiponectin and leptin will be obtained the next morning.
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1 day
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Athanasios D Anastasilakis, MD, PhD、424 General Military Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2013年11月9日
首先提交符合 QC 标准的
2013年11月12日
首次发布 (估计)
2013年11月18日
研究记录更新
最后更新发布 (估计)
2015年1月22日
上次提交的符合 QC 标准的更新
2015年1月20日
最后验证
2015年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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