Obesity Clinical Trial
— HEPAFITOfficial title:
Effects of an Exercise Program on Hepatic Metabolism and Cardiovascular Health in Overweight/Obese Adolescent From Bogota, Colombia (HEPAFIT Study)
NCT number | NCT02753231 |
Other study ID # | UR-21042016 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | December 2017 |
Verified date | November 2018 |
Source | Universidad Santo Tomas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits on hepatic metabolism and cardiovascular health as well as on selected physical fitness and mental health outcomes among adolescent overweight/obese from Bogota, Colombia.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Overweight or obesity status - 11-17 years old - Written informed consent - Interested in improving health and fitness Exclusion Criteria: - Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial. - Clinical diagnosis of diabetes - Pregnancy - Drugs/alcohol abuse |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universidad Santo Tomas | Emory University, Universidad de Granada, Universidad de Santiago de Chile, Universidad Pública de Navarra, University of Castilla-La Mancha |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®) | Changes in hepatic fat fraction measured by controlled attenuation parameter after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in liver enzymes | Changes in total alanine transaminase (ALT) after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in serum lipid profile | Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA) | Changes in insulin sensitivity measured by homeostasis model assessment (HOMA) after the 6 months intervention program | Baseline and 6 months | |
Secondary | Change from Baseline in Aerobic fitness measured on a maximum effort test | Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test | Baseline and 6 months | |
Secondary | Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment) | Muscular fitness will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III® | Baseline and 6 months | |
Secondary | Change from Baseline in Body composition | Fat mass as measured by Dual Energy X-ray Absorptiometry | Baseline and 6 months | |
Secondary | Changes in physical activity using accelerometry | Changes in physical activity estimated by accelerometry after the 6 months intervention program | Baseline and 6 months | |
Secondary | Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version | Baseline and 6 months | ||
Secondary | Changes in blood pressure | Changes in blood pressure after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in liver enzymes | Changes in total gamma-GT after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in liver enzymes | Changes in total aspartate transaminase (AST) after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in inflammatory markers after the 6 months intervention program | Changes in TNF-alpha after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in inflammatory markers after the 6 months intervention program | Changes in IL-6 and IL-10 after the 6 months intervention program | Baseline and 6 months | |
Secondary | Changes in inflammatory markers after the 6 months intervention program | Changes in C-reactive protein (CRP) after the 6 months intervention program | Baseline and 6 months | |
Secondary | Change from Baseline in Body composition | Lean body mass as measured by Dual Energy X-ray Absorptiometry | Baseline and 6 months |
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