Obesity Clinical Trial
— EFIGROOfficial title:
The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study
NCT number | NCT02258126 |
Other study ID # | PI13/01335 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | January 2018 |
Verified date | March 2019 |
Source | Basque Country University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the present study is to evaluate the effect of 6 months exercise
intervention program on hepatic fat fraction in overweight children.
Methodology: A total of 160 children, 9-11 years old, will be randomly assigned to control
(N=80) or intervention (N=80) groups. Training sessions will include 90 minutes of exercise,
comprising warm-up and skill development. The control group will attend a healthy lifestyle
education program (2 days/month) and the intervention group an exercise (3 days/week) and
healthy lifestyle education (2 days/month) combined program. Before and after the
intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk
factors will be measured. Furthermore, dietary habits and physical activity, blood pressure
and pubertal development will be evaluated before and after the intervention.
Status | Completed |
Enrollment | 115 |
Est. completion date | January 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Overweight or obesity status - 9-11 years old Exclusion Criteria: - Medical conditions that hamper their participation in the exercise program - Secondary obesity |
Country | Name | City | State |
---|---|---|---|
Spain | Pediatric Endocrinology Unit of the University Hospital of Araba (HUA) | Vitoria-Gasteiz | Araba |
Lead Sponsor | Collaborator |
---|---|
Basque Country University |
Spain,
Akin L, Kurtoglu S, Yikilmaz A, Kendirci M, Elmali F, Mazicioglu M. Fatty liver is a good indicator of subclinical atherosclerosis risk in obese children and adolescents regardless of liver enzyme elevation. Acta Paediatr. 2013 Mar;102(3):e107-13. doi: 10 — View Citation
Davis CL, Pollock NK, Waller JL, Allison JD, Dennis BA, Bassali R, Meléndez A, Boyle CA, Gower BA. Exercise dose and diabetes risk in overweight and obese children: a randomized controlled trial. JAMA. 2012 Sep 19;308(11):1103-12. — View Citation
Escalante Y, Saavedra JM, García-Hermoso A, Domínguez AM. Improvement of the lipid profile with exercise in obese children: a systematic review. Prev Med. 2012 May;54(5):293-301. doi: 10.1016/j.ypmed.2012.02.006. Epub 2012 Feb 23. Review. — View Citation
Hallsworth K, Fattakhova G, Hollingsworth KG, Thoma C, Moore S, Taylor R, Day CP, Trenell MI. Resistance exercise reduces liver fat and its mediators in non-alcoholic fatty liver disease independent of weight loss. Gut. 2011 Sep;60(9):1278-83. doi: 10.113 — View Citation
Koot BG, van der Baan-Slootweg OH, Tamminga-Smeulders CL, Rijcken TH, Korevaar JC, van Aalderen WM, Jansen PL, Benninga MA. Lifestyle intervention for non-alcoholic fatty liver disease: prospective cohort study of its efficacy and factors related to impro — View Citation
Kotronen A, Yki-Järvinen H. Fatty liver: a novel component of the metabolic syndrome. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):27-38. Epub 2007 Aug 9. Review. — View Citation
Lee S, Bacha F, Hannon T, Kuk JL, Boesch C, Arslanian S. Effects of aerobic versus resistance exercise without caloric restriction on abdominal fat, intrahepatic lipid, and insulin sensitivity in obese adolescent boys: a randomized, controlled trial. Diab — View Citation
Nobili V, Manco M. Therapeutic strategies for pediatric non-alcoholic fatty liver disease: a challenge for health care providers. World J Gastroenterol. 2007 May 14;13(18):2639-41. — View Citation
Oh S, Tanaka K, Warabi E, Shoda J. Exercise reduces inflammation and oxidative stress in obesity-related liver diseases. Med Sci Sports Exerc. 2013 Dec;45(12):2214-22. doi: 10.1249/MSS.0b013e31829afc33. — View Citation
Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular risk factors and the metabolic syndrome in pediatric nonalcoholic fatty liver disease. Circulation. 2008 Jul 15;118(3):277-83. doi: 10.1161/CIRCULATIONAHA.107.739920. Epub 2008 Jun 30. — View Citation
Volovelsky O, Weiss R. Fatty liver disease in obese children--relation to other metabolic risk factors. Int J Pediatr Obes. 2011 Sep;6 Suppl 1:59-64. doi: 10.3109/17477166.2011.583661. — View Citation
Welsh JA, Karpen S, Vos MB. Increasing prevalence of nonalcoholic fatty liver disease among United States adolescents, 1988-1994 to 2007-2010. J Pediatr. 2013 Mar;162(3):496-500.e1. doi: 10.1016/j.jpeds.2012.08.043. Epub 2012 Oct 17. — View Citation
Wicklow BA, Wittmeier KD, MacIntosh AC, Sellers EA, Ryner L, Serrai H, Dean HJ, McGavock JM. Metabolic consequences of hepatic steatosis in overweight and obese adolescents. Diabetes Care. 2012 Apr;35(4):905-10. doi: 10.2337/dc11-1754. Epub 2012 Feb 22. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in hepatic fat | Changes in hepatic fat fraction measured by magnetic resonance imaging after the 6 months intervention program | baseline and 6 months | |
Secondary | Changes in Insulin sensitivity | Changes in insulin sensitivu¡ity measured by homeostasis model assessment (HOMA) after the 6 months intervention program | baseline and 6 months | |
Secondary | Changes in serum lipid profile | Changes in total, LDL- and HDL-cholesterol after the 6 months intervention program | baseline and 6 months | |
Secondary | Changes in liver enzymes | Changes in total, alanine transaminase (ALT), aspartate transaminase (AST) and gamma-GT after the 6 months intervention program | baseline and 6 months | |
Secondary | Changes in dietary habits | Changes in dietary habits estimated by 24h recall and food frequency questionnaire after the 6 months intervention program | baseline and 6 months | |
Secondary | Changes in physical activity | Changes in physical activity estimated by accelerometry after the 6 months intervention program | baseline and 6 months | |
Secondary | Changes in body composition | Changes in visceral adipose tissue (MRI), abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 6 months intervention program | baseline and 6 months | |
Secondary | Changes in other cardiometabolic risk factors | Changes in blood pressure, leptin, adiponectin, C-reactive protein (CRP) after the 6 months intervention program | baseline and 6 months |
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