Correlation of Irisin and Adipokine Levels With Body Mass Index and Risk Factors for Metabolic Syndrome in Hispanic Children

NCT02320110 | Completed

• 1 other identifier: DIETARYHABITS2014-CINCO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity; Thinness

Keywords

Irisin; Adiponectin; Leptin; Insulin resistance; Body Mass Index; Obesity; Metabolic Syndrome; Lipid Profile; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Irisin levels identification in Hispanic children

  3 months

• Correlation of irisin levels with body mass index percentiles in Hispanic children

  Correlation of irisin plasma levels with body mass index percentiles

  3 months

• 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

Secondary Outcomes (1)

• Irisin plasma levels and adiponectin, leptin, insulin and resistin.

  3 months

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Obese, overweight, normal weight and underweight Hispanic, school-aged children from eight public schools representative of Monterrey, the second largest city in México.

You may qualify if:

• Attendance to school from first to sixth grade
• Ages 6-12 years
• Hispanic origin
• Both parents Hispanic
• hour overnight fast
• Signed consent from both parents/care givers and active assent from children

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead

Study Sites (1)

Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey

Monterrey, Nuevo León, 64710, Mexico

Location

Related Publications (24)

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  BACKGROUND

• Secretaría de Salud. México avanza en la cobertura universal de salud: Felipe Calderón. México Sano. 2009;8:3.

  BACKGROUND

• Saunders J, Smith T, Stroud M. Malnutrition and undernutrition. Medicine 39(1): 45-50, 2011

  BACKGROUND

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• Elizondo, L. Hernández, C. Zamora, M. (2011). Terapia Nutricia Médica en Ginecología y Obstetricia. México: McGraw-Hill.

  BACKGROUND

• Pedersen BK, Febbraio MA. Muscles, exercise and obesity: skeletal muscle as a secretory organ. Nat Rev Endocrinol. 2012 Apr 3;8(8):457-65. doi: 10.1038/nrendo.2012.49.

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• Bostrom P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Bostrom EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Hojlund K, Gygi SP, Spiegelman BM. A PGC1-alpha-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012 Jan 11;481(7382):463-8. doi: 10.1038/nature10777.

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• Sanchis-Gomar F, Lippi G, Mayero S, Perez-Quilis C, Garcia-Gimenez JL. Irisin: a new potential hormonal target for the treatment of obesity and type 2 diabetes. J Diabetes. 2012 Sep;4(3):196. doi: 10.1111/j.1753-0407.2012.00194.x. No abstract available.

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• Stengel A, Hofmann T, Goebel-Stengel M, Elbelt U, Kobelt P, Klapp BF. Circulating levels of irisin in patients with anorexia nervosa and different stages of obesity--correlation with body mass index. Peptides. 2013 Jan;39:125-30. doi: 10.1016/j.peptides.2012.11.014. Epub 2012 Dec 3.

  PMID: 23219488 BACKGROUND

• 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.

  PMID: 23018146 BACKGROUND

• Roca-Rivada A, Castelao C, Senin LL, Landrove MO, Baltar J, Belen Crujeiras A, Seoane LM, Casanueva FF, Pardo M. FNDC5/irisin is not only a myokine but also an adipokine. PLoS One. 2013 Apr 11;8(4):e60563. doi: 10.1371/journal.pone.0060563. Print 2013.

  PMID: 23593248 BACKGROUND

• Crujeiras AB, Zulet MA, Lopez-Legarrea P, de la Iglesia R, Pardo M, Carreira MC, Martinez 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.

  PMID: 24439241 BACKGROUND

• Pardo M, Crujeiras AB, Amil M, Aguera Z, Jimenez-Murcia S, Banos R, Botella C, de la Torre R, Estivill X, Fagundo AB, Fernandez-Real JM, Fernandez-Garcia JC, Fruhbeck G, Gomez-Ambrosi J, Rodriguez R, Tinahones FJ, Fernandez-Aranda F, Casanueva FF. Association of irisin with fat mass, resting energy expenditure, and daily activity in conditions of extreme body mass index. Int J Endocrinol. 2014;2014:857270. doi: 10.1155/2014/857270. Epub 2014 Apr 22.

  PMID: 24864142 BACKGROUND

• 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.

  PMID: 24057291 BACKGROUND

• 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.

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• Moreno-Navarrete JM, Ortega F, Serrano M, Guerra E, Pardo G, Tinahones F, Ricart W, Fernandez-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.

  PMID: 23436919 BACKGROUND

• Bluher 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.

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• Al-Daghri NM, Alkharfy KM, Rahman S, Amer OE, Vinodson B, Sabico S, Piya MK, Harte AL, McTernan PG, Alokail MS, Chrousos GP. Irisin as a predictor of glucose metabolism in children: sexually dimorphic effects. Eur J Clin Invest. 2014 Feb;44(2):119-24. doi: 10.1111/eci.12196. Epub 2013 Dec 6.

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• McTernan PG, Kusminski CM, Kumar S. Resistin. Curr Opin Lipidol. 2006 Apr;17(2):170-5. doi: 10.1097/01.mol.0000217899.59820.9a.

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MeSH Terms

Conditions

Overweight; Obesity; Thinness; Insulin Resistance; Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Leticia Elizondo-Montemayor, MD

  Clinical Nutrition and Obesity Research Center. TEC Salud, School of Medicine Tecnológico de Monterrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine TEC Salud. Tecnológico de Monterrey.

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 19, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

ME (1)