- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00951392
Implication of Metabolic and Genomic Modifications in Elderly Subjects (COMPALICLAMP)
An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle).
In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging.
The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pierre-Bénite, Francia, 69495
- Centre de Recherche en Nutrition Humaine Rhône-Alpes
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Volunteers from the cohort aging SUVIMAX 2
- Men and Women
- over 60 years
- BMI between 18 and 35 kg/m2 (including terminals)
- Normal medical check up
- Blood pressure < 140/90 mmHg
- Normal glycemia, lipid profile
- sedentary or moderate physical activity (maximum 4 hours per week)
Exclusion Criteria:
- Biological results or anormal chek-up
- medical or surgical history not compatible with study
- severe digestive, cardiovascular, renal, liver or tumor disorders history in the 5 last years
- infectious or inflammatory disease within 2 months
- surgical history within 3 months
- bood donation within 2 months
- coagulation disease, anticoagulant or antiplatelet agents (aspirin ...) treatment
- xylocaïn allergy
- claustrophobia
- Drug that could affect insulin sensitivity (beta blockers, lipid lowering, oral antidiabetics, insulin, , steroids)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Problematic aging
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Insulin perfusion at 1 mU.kg-1.min-1 Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l Blood tests Gene expression in muscle tissue will be studied with two approaches :
energy expenditure measurement
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Sperimentale: successful aging
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Insulin perfusion at 1 mU.kg-1.min-1 Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l Blood tests Gene expression in muscle tissue will be studied with two approaches :
energy expenditure measurement
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality
Lasso di tempo: 120 minutes
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120 minutes
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Gene expression in muscle tissue by quantitative RT-PCR: genes involved in the carbohydrates and lipids metabolism (lipid carriers, PPARs), 7 sirtuins isoforms and of their target genes (NFkB, PGC1a)
Lasso di tempo: one day
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one day
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Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip
Lasso di tempo: one day
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one day
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Martine LAVILLE, MD, PhD, Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2008.547
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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