Obesity Clinical Trial
Official title:
Correlation of Circulating Irisin and Adipokine Levels Across a Broad Spectrum of Body Mass Index Ranging From Undernourished to Obese and With Insulin Resistance and Risk Factors for the Metabolic Syndrome in Hispanic Children
Childhood obesity is one of the most serious global public health challenges of the 21st
century (Daniels et al., 2009). Mexico has the highest prevalence of obesity, (Secretaría de
Salud, 2009); 34.4% of children and 35% of adolescents are overweight or obese (ENSANUT
2012). Obesity has major health consequences for children and adolescents; On the other
hand, undernutrition as well has important deleterious consequences on children's health.
Anything that disrupts energy balance may cause individuals to be underweight, overweight or
obese. Fat has been considered an endocrine organ for some time (Elizondo, 2011). Recently,
skeletal muscle has been shown to function as a peripheral endocrine organ by releasing
myokines, (Pedersen, 2012). Most recently, a new identified hormone secreted by muscle
tissue in mouse, irisin, has been discovered. Irisin acts on white adipose cells in culture
and in vivo to stimulate UCP1 expression and a broad program of brown-fat-like development.
Irisin was induced with exercise in mice and humans which caused an increase in energy
expenditure in mice with no changes in movement or food intake (Boström et al., 2012).
Irisin was thus, promptly hypothesized as a hormone influencing body weight, obesity and
type 2 diabetes mellitus, among other conditions (Sanchis-Gomar et al., 2012). Some studies
have indicated that circulating levels of irisin in humans correlate positively with
anthropometric parameters such as BMI, fat mass, fat free mass, and are higher in obese
patients compared to lean ones (Stengel et al., 2013; Huh et al., 2012; Roca-Rivada et al.,
2013; Crujeiras et al., 2014; Pardo, 2014). Studies have shown an association between irisin
levels, insulin resistance and the metabolic syndrome (Park et al., 2013; de la Iglesia et
al., 2014; Crujeiras et al., 2014; Pardo et al., 2014). However, some others have found a
negative correlation with anthropometric parameters, finding lower irisin levels in obese
patients (Moreno-Navarrete et al., 2013). Noteworthy, all these studies have been performed
in adults. To date, there are only two studies evaluating irisin levels in children. One
found that a 1-year long lifestyle intervention program was associated with an elevation in
irisin levels in obese children, although no correlation was found between irisin levels and
anthropometric markers (Blüher et al., 2014). The other study investigated normal weight
Saudi children and found correlations between circulating irisin and glucose and HDLc, but a
negative association with insulin resistance (Al-Daghri et al, 2014).
Besides, associations between irisin levels and adiponectin, leptin and resistin in the set
of obesity have been explored, the three of them are implicated in the physiopatology of
obesity.
As there are still conflicting data regarding the association of irisin with anthropometric
parameters, obesity and the metabolic syndrome, as well as its 'association with other
adiponectines, and most important, there is scarce data of these associations in children,
the objective of this study will be to correlate the circulating irisin and adipokines
levels across a broad spectrum of body mass index ranging from undernourished to obese as
well as with insulin resistance and risk factors for the metabolic syndrome in Hispanic
children.
The sample size with statistical power for this study yielded a sample of 40 children.
Frozen stored plasma (-80°C) will be taken from a previous study performed in children which
has been published (Elizondo-Montemayor et al., 2014). The samples will be divided into five
groups, 8 per group, according to the CDC and American Academy of Pediatrics body mass index
percentile classification: 1.) underweight = <3 percentile; 2.) normal weight = >3 - < 85
percentile; 3.) Overweight = >85 - < 95 percentile, and 4.) obese = > 95 percentile. The
fifth group will correspond to children with known metabolic syndrome according to the
classification specified by Cooks et al (2008). Anthropometric measurements will include
BMI, percentile BMI, waist circumference, % body fat, fat mass, fat free mass, and triceps
skin fold. Biochemical measurements will include glucose, total cholesterol, low-density
cholesterol (LDL), high-density cholesterol (HDL-c) and triglycerides. Clinical measurements
will include blood pressure, physical activity records and dietary habits. All biochemical,
anthropometric and clinical measurements were previously performed in a former published
study (Elizondo-Montemayor et al., 2014).
Irisin, adiponectin and leptin will be measured in plasma media using commercial ELISA kits.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Attendance to school from first to sixth grade - Ages 6-12 years - Hispanic origin - Both parents Hispanic - 12 hour overnight fast - Signed consent from both parents/care givers and active assent from children Exclusion Criteria: - Disapproval by the children's physician due to any at-risk medical condition known by the parents - Use of drugs for high blood pressure, hyperglycemia, or dyslipidemia |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Mexico | Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Instituto Tecnologico y de Estudios Superiores de Monterey |
Mexico,
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Blüher S, Panagiotou G, Petroff D, Markert J, Wagner A, Klemm T, Filippaios A, Keller A, Mantzoros CS. Effects of a 1-year exercise and lifestyle intervention on irisin, adipokines, and inflammatory markers in obese children. Obesity (Silver Spring). 2014 Jul;22(7):1701-8. doi: 10.1002/oby.20739. Epub 2014 Mar 25. — View Citation
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Crujeiras AB, Zulet MA, Lopez-Legarrea P, de la Iglesia R, Pardo M, Carreira MC, Martínez JA, Casanueva FF. Association between circulating irisin levels and the promotion of insulin resistance during the weight maintenance period after a dietary weight-lowering program in obese patients. Metabolism. 2014 Apr;63(4):520-31. doi: 10.1016/j.metabol.2013.12.007. Epub 2013 Dec 18. — View Citation
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de la Iglesia R, Lopez-Legarrea P, Crujeiras AB, Pardo M, Casanueva FF, Zulet MA, Martinez JA. Plasma irisin depletion under energy restriction is associated with improvements in lipid profile in metabolic syndrome patients. Clin Endocrinol (Oxf). 2014 Aug;81(2):306-11. doi: 10.1111/cen.12383. Epub 2014 Jan 7. — View Citation
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Moreno-Navarrete JM, Ortega F, Serrano M, Guerra E, Pardo G, Tinahones F, Ricart W, Fernández-Real JM. Irisin is expressed and produced by human muscle and adipose tissue in association with obesity and insulin resistance. J Clin Endocrinol Metab. 2013 Apr;98(4):E769-78. doi: 10.1210/jc.2012-2749. Epub 2013 Feb 22. — View Citation
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Park KH, Zaichenko L, Brinkoetter M, Thakkar B, Sahin-Efe A, Joung KE, Tsoukas MA, Geladari EV, Huh JY, Dincer F, Davis CR, Crowell JA, Mantzoros CS. Circulating irisin in relation to insulin resistance and the metabolic syndrome. J Clin Endocrinol Metab. 2013 Dec;98(12):4899-907. doi: 10.1210/jc.2013-2373. Epub 2013 Sep 20. Erratum in: J Clin Endocrinol Metab. 2014 May;99(5):1910. — View Citation
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Irisin levels identification in Hispanic children | 3 months | No | |
Primary | Correlation of irisin levels with body mass index percentiles in Hispanic children | Correlation of irisin plasma levels with body mass index percentiles | 3 months | No |
Primary | Correlation of irisin leves with risk factors for metabolic syndrome in Hispanic children | The risk factors include: waist circumference, % body fat, triceps skin fold, fat mass, fat free mass and blood presurre measurements, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides and glucose serum levels | 3 months | No |
Secondary | Irisin plasma levels and adiponectin, leptin, insulin and resistin. | correlation of irisin plasma levels adiponectin, leptin, resistin and insluin | 3 months | No |
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