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

13 ottobre 2022 aggiornato da: Babu Balagopal, Nemours Children's Clinic

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).

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

A. SPECIFIC AIMS:

Evidence from the literature suggests that:

  1. childhood onset of obesity increases the risk of obesity and cardiovascular disease (CVD) in adulthood;
  2. plasma fibrinogen and apolipoprotein B-100 (apoB-100) levels are elevated in obesity;
  3. elevated levels of plasma fibrinogen and apolipoprotein B-100 (apoB-100) are major independent risk factors for CVD in adults;
  4. raised plasma fibrinogen levels in obese children and/adolescents could be a major factor responsible for CVD morbidity and mortality in adulthood;
  5. a low level of physical activity is associated with a high level of plasma fibrinogen in adults;
  6. physical training and controlled diet have been proved to be non-pharmacological ways to improve hemostatic function in adults, thereby reducing heart disease risk. Despite these evidences the mechanism of these changes remain unclear. A better understanding of the mechanism of these changes will lead to more directed therapies to reduce these risk factors early in life.

The increased plasma concentrations of fibrinogen (and/or other proteins) is decided by the equilibrium between two dynamic processes in the body, namely, synthesis and degradation rates of these proteins. Therefore, elevated levels of fibrinogen must be a consequence of:

  1. increased fibrinogen synthesis;
  2. decreased fibrinogen degradation or
  3. a contribution of both.

For designing effective therapies it is important to know, whether the increased concentration of plasma fibrinogen is due to increased synthesis or decreased degradation or both. Using stable isotope mass spectrometry techniques it is possible to measure the synthesis rates of proteins in vivo in humans. Yet until now there are no reports on the direct measurement of FSR of fibrinogen and/or apoB-100 in childhood obesity, important CVD risk factors. The direct measurement of degradation rates of proteins in vivo in humans, however, is not easily done. Few studies have reported changes in the concentrations of fibrinolytic markers such as plasminogen activator inhibitor-1 (PAI-1) and D-Dimer in obesity. This, however, accounts for only a small fraction of the elevated levels of plasma fibrinogen in childhood obesity. On the other hand recent preliminary results in three subjects from our lab show that fibrinogen synthesis rate is substantially higher (more than two times) in obese adolescent girls Vs lean controls (please see results under "Preliminary results" below). Pro-inflammatory cytokines, particularly interleukin-6 (IL-6), are known to play an important role in the regulation of acute phase reactive proteins associated with inflammation, including fibrinogen. A direct link between IL-6 and increased FSR of plasma fibrinogen in childhood obesity and CVD, however, is unknown. Also, other mechanisms involving insulin resistance and free fatty acid/albumin ratio are also equally plausible for the increased synthesis of fibrinogen in obesity and CVD. Therefore, it is important to understand and establish the relationship between increased FSR of fibrinogen and these regulating factors in this study for two reasons:

  1. to better design effective therapies based on these results and
  2. to further understand the pathophysiology of these changes in CVD and obesity.

The overall purpose of the proposed studies is therefore:

  1. to expand on our preliminary data and establish the observation of increased fibrinogen synthesis rate (in three subjects) in childhood obesity
  2. to understand the relationship between increased FSR of fibrinogen and changes IL-6, insulin and glucose levels and free fatty acid (FFA) levels and FFA/albumin ratio in obese vs lean children
  3. to study the effect of a non-pharmacological intervention program for three months (12 weeks), that involves weight reduction due to exercise and controlled diet on fibrinogen, apoB-100 and other cardiovascular risk factors and their relationship to changes in IL-6 levels, insulin/glucose ratio (a measure of insulin resistance), FFA/albumin ratio.

The proposed grant will use in vivo stable isotope (non-radioactive) dilution techniques, to test the following hypothesis:

Hypotheses:

  1. higher rates of synthesis of fibrinogen and apoB-100 contribute substantially to their elevated levels in obese children;
  2. plasma fibrinogen and apoB-100 concentration and synthesis decrease by non-pharmacological intervention to reduce weight, that involves regular physical exercise and controlled diet;
  3. IL-6 and/or insulin resistance are important mechanistic links between increased plasma fibrinogen FSR and increased CVD risk and obesity and
  4. the non-pharmacological intervention program modulates other CVD risk factors such as PAI-1, D-Dimer, homocysteine, free fatty acids, insulin, glucose, HDL and LDL cholesterol levels and IL-6 concentrations along with fibrinogen synthesis.

Summary of Specific Aims

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 14 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Obese: BMI ≥30 kg/m2
  • Lean (controls): BMI ≤ 25 kg/m2) age 14 to 18 years and Tanner stage matched
  • Ability to understand and cooperate with the procedures
  • Signed informed consent from subjects and parents

Exclusion Criteria:

  • Medications such as Beta-adrenergic blockers, steroids and other drugs known to affect protein metabolism
  • Heart disease
  • Chronic liver disease
  • Chronic renal disease
  • Active malignancy
  • Alcoholism or drug abuse
  • Anemia
  • Inter-current illness over the 7 days before the study
  • Surgery in the past 3 months

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
12 weeks of lifestyle-based physical activity intervention
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.
Nessun intervento: Control
12 weeks of no intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Protein turnover
Lasso di tempo: 12 weeks
Stable isotope mass spectrometry
12 weeks
Fractional synthesis rate of fibrinogen
Lasso di tempo: 12 weeks
Stable isotope mass spectrometry
12 weeks
Fibrinogen
Lasso di tempo: 12 weeks
Plasma concentration measured by nephelometry
12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fat mass
Lasso di tempo: 12 weeks
Dual-energy X-ray absorptiometry (DEXA)
12 weeks
Fat free mass
Lasso di tempo: 12 weeks
Dual-energy X-ray absorptiometry (DEXA)
12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Babu Balagopal, PhD, Nemours Children's Clinic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2001

Completamento primario (Effettivo)

1 gennaio 2004

Completamento dello studio (Effettivo)

1 dicembre 2020

Date di iscrizione allo studio

Primo inviato

19 novembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

23 novembre 2015

Primo Inserito (Stima)

24 novembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • C.20.8840
  • 0030342B (Altro numero di sovvenzione/finanziamento: American AHeart Association)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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