Effect of Exercise on Hepatic Fat in Overweight Children

Obesity Clinical Trial

— EFIGRO  

Official title:

The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258126
• Other study ID #: PI13/01335
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: January 2018

Study information

• Verified date: March 2019
• Source: Basque Country University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The control group will attend a healthy lifestyle education program (2 days/month) and supportive therapy and behavioral advice for both children and parents to improve nutrition and physical activity (nutritionists and psychologists).

The intervention group will attend an exercise (3 days/week) and healthy lifestyle education (2 days/month) combined program. Training sessions will include 90 minutes of exercise, comprising warm-up and skill development, moderate to vigorous aerobic activities, flexibility and strength exercises.

Before (baseline) and after the intervention (6 months) total and abdominal adiposity, lean tissue mass and bone mass density (dual-X-ray-absorptiometry), abdominal visceral and hepatic adiposity (magnetic resonance imaging), and blood insulin, glucose, C-reactive protein, alanine aminotransferase, aspartate aminotransferase, gamma-glutamil transpeptidase and lipid profile will be measured. Furthermore, cardiorespiratory fitness (treadmill test) and blood pressure will be measured before and after the intervention. Changes (6 months - baseline) in dietary habits will be estimated by using two repeated 24h recalls and food frequency questionnaires and changes (6 months - baseline) in physical activity by accelerometry.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Syndrome
• Non-alcoholic Fatty Liver Disease
• Obesity
• Overweight

Intervention

Other:
• Multidisciplinary intervention program
Exercise group: The intervention program includes an education program promoting healthy dietary habits and physical activity (nutritionist), supportive therapy and behavioral advice for the family to improve nutrition and physical activity (psychologist) (2 times/month, for children and parents) and supervised exercise (3 times/week, 90 mins) program for 6 months.

Locations

Country	Name	City	State
Spain	Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)	Vitoria-Gasteiz	Araba

Sponsors (1)

Lead Sponsor	Collaborator
Basque Country University

Country where clinical trial is conducted

Spain, 

References & Publications (13)

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

Outcome

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