- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02613741
Metabolism of Fibrinogen and Apolipoprotein B-100 in Childhood Obesity and Cardiovascular Disease
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:
- 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
- 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
- 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
- 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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A. SPECIFIC AIMS:
Evidence from the literature suggests that:
- childhood onset of obesity increases the risk of obesity and cardiovascular disease (CVD) in adulthood;
- plasma fibrinogen and apolipoprotein B-100 (apoB-100) levels are elevated in obesity;
- elevated levels of plasma fibrinogen and apolipoprotein B-100 (apoB-100) are major independent risk factors for CVD in adults;
- raised plasma fibrinogen levels in obese children and/adolescents could be a major factor responsible for CVD morbidity and mortality in adulthood;
- a low level of physical activity is associated with a high level of plasma fibrinogen in adults;
- 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:
- increased fibrinogen synthesis;
- decreased fibrinogen degradation or
- 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:
- to better design effective therapies based on these results and
- to further understand the pathophysiology of these changes in CVD and obesity.
The overall purpose of the proposed studies is therefore:
- to expand on our preliminary data and establish the observation of increased fibrinogen synthesis rate (in three subjects) in childhood obesity
- 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
- 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:
- higher rates of synthesis of fibrinogen and apoB-100 contribute substantially to their elevated levels in obese children;
- plasma fibrinogen and apoB-100 concentration and synthesis decrease by non-pharmacological intervention to reduce weight, that involves regular physical exercise and controlled diet;
- IL-6 and/or insulin resistance are important mechanistic links between increased plasma fibrinogen FSR and increased CVD risk and obesity and
- 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:
- 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
- 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
- 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
- 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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: Control
12 weeks of no intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Protein turnover
Tidsramme: 12 weeks
|
Stable isotope mass spectrometry
|
12 weeks
|
|
Fractional synthesis rate of fibrinogen
Tidsramme: 12 weeks
|
Stable isotope mass spectrometry
|
12 weeks
|
|
Fibrinogen
Tidsramme: 12 weeks
|
Plasma concentration measured by nephelometry
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fat mass
Tidsramme: 12 weeks
|
Dual-energy X-ray absorptiometry (DEXA)
|
12 weeks
|
|
Fat free mass
Tidsramme: 12 weeks
|
Dual-energy X-ray absorptiometry (DEXA)
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Babu Balagopal, PhD, Nemours Children's Clinic
Publikationer og nyttige links
Generelle publikationer
- Balagopal P, Bayne E, Sager B, Russell L, Patton N, George D. Effect of lifestyle changes on whole-body protein turnover in obese adolescents. Int J Obes Relat Metab Disord. 2003 Oct;27(10):1250-7. doi: 10.1038/sj.ijo.0802388.
- Balagopal P, George D, Patton N, Yarandi H, Roberts WL, Bayne E, Gidding S. Lifestyle-only intervention attenuates the inflammatory state associated with obesity: a randomized controlled study in adolescents. J Pediatr. 2005 Mar;146(3):342-8. doi: 10.1016/j.jpeds.2004.11.033.
- Balagopal P, George D, Yarandi H, Funanage V, Bayne E. Reversal of obesity-related hypoadiponectinemia by lifestyle intervention: a controlled, randomized study in obese adolescents. J Clin Endocrinol Metab. 2005 Nov;90(11):6192-7. doi: 10.1210/jc.2004-2427. Epub 2005 Aug 30.
- Balagopal P, Graham TE, Kahn BB, Altomare A, Funanage V, George D. Reduction of elevated serum retinol binding protein in obese children by lifestyle intervention: association with subclinical inflammation. J Clin Endocrinol Metab. 2007 May;92(5):1971-4. doi: 10.1210/jc.2006-2712. Epub 2007 Mar 6.
- Balagopal P, George D, Sweeten S, Mann KJ, Yarandi H, Mauras N, Vaughan DE. Response of fractional synthesis rate (FSR) of fibrinogen, concentration of D-dimer and fibrinolytic balance to physical activity-based intervention in obese children. J Thromb Haemost. 2008 Aug;6(8):1296-303. doi: 10.1111/j.1538-7836.2008.03037.x. Epub 2008 May 26.
- Balagopal PB, Gidding SS, Buckloh LM, Yarandi HN, Sylvester JE, George DE, Funanage VL. Changes in circulating satiety hormones in obese children: a randomized controlled physical activity-based intervention study. Obesity (Silver Spring). 2010 Sep;18(9):1747-53. doi: 10.1038/oby.2009.498. Epub 2010 Jan 21.
- Lovely R, Hossain J, Ramsey JP, Komakula V, George D, Farrell DH, Balagopal PB. Obesity-related increased gamma' fibrinogen concentration in children and its reduction by a physical activity-based lifestyle intervention: a randomized controlled study. J Pediatr. 2013 Aug;163(2):333-8. doi: 10.1016/j.jpeds.2013.01.004. Epub 2013 Feb 14.
- Cosentino RG, Churilla JR, Josephson S, Molle-Rios Z, Hossain MJ, Prado WL, Balagopal PB. Branched-chain Amino Acids and Relationship With Inflammation in Youth With Obesity: A Randomized Controlled Intervention Study. J Clin Endocrinol Metab. 2021 Oct 21;106(11):3129-3139. doi: 10.1210/clinem/dgab538.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C.20.8840
- 0030342B (Andet bevillings-/finansieringsnummer: American AHeart Association)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lifestyle-based physical activity
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrutteringFysisk aktivitet | Insulin resistens | Pubertet | PCOS (polycystisk ovariesyndrom)Forenede Stater
-
Gazi UniversityIkke rekrutterer endnu
-
University of Vic - Central University of CataloniaIRIS-CC; AGAURAktiv, ikke rekrutterendePsykisk sundhedsproblemSpanien
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetFysisk aktivitetForenede Stater
-
The Miriam HospitalUkendtSlag | Stillesiddende livsstil | Iskæmisk angreb, forbigående | Dyrke motionForenede Stater
-
Centre Hospitalier Universitaire de Saint EtienneNational Cancer Institute, FranceAfsluttetKræft prostataFrankrig
-
The University of Hong KongRekrutteringDemens | Plejerbyrde | Kognitiv svækkelse, mild | Demens, mildHong Kong
-
Northeastern UniversitySociety for Pediatric Psychology; APA: American Psychological AssociationRekrutteringAutismespektrumforstyrrelse (ASD)Forenede Stater
-
Cairo UniversityTilmelding efter invitation