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Metabolism of Fibrinogen and Apolipoprotein B-100 in Childhood Obesity and Cardiovascular Disease

NCT02613741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-10-14

No results posted yet for this study

Summary

Since obesity and plasma fibrinogen levels are important CVD risk factors in the adults, and since childhood obesity is a major risk factor for adult obesity and also because it is not established whether or not this is due to an increase in the FSR of fibrinogen, the investigators set up the studies with the following specific aims:

1. To investigate the metabolism of fibrinogen and VLDL apoB-100, CVD risk factors, in childhood obesity by measuring their fractional synthetic rate (FSR) compared to lean age and sex matched controls
2. To determine the outcome of a three month non-pharmacological intervention (physical exercise combined with controlled diet) to reduce weight on the FSR of fibrinogen and apoB-100
3. To determine the relationship between FSR of fibrinogen and IL-6 in obese children and its potential implications on CVD before and after the non-pharmacological intervention
4. To determine other CVD risk factors, PAI-1 levels, D-Dimer concentration, homocysteine, insulin, free fatty acid, HDL \& LDL cholesterol and blood pressure in response to weight reduction (as consequence of a combined program of diet and exercise).

Conditions

Interventions

OTHER

Lifestyle-based physical activity

Obese subjects will undergo a randomized physical activity-based weight reduction program (12 weeks). The lifestyle intervention will be determined based on an initial evaluation of each subjects' energy expenditure (by indirect calorimetry). Caloric intake will be set to elicit the loss of 1 to 1.5 lbs/week. The subjects and the family will meet with a dietitian once/week for 12 weeks. The intervention group will undergo an aerobic exercise program 3 times/week. The duration of exercise will be progressively increased from 20 to 45 minutes/session. The subjects will keep daily record of exercise activity and food intake. Interventions will be monitored during the subjects' weekly visit with the research group and they will be given counseling to stick to the intervention program.

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Babu Balagopal, PhD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2004-01-31
Completion
2020-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613741 on ClinicalTrials.gov