- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02244736
Vascular Markers During OGTT in Diabetics and First-degree Relatives
Changes of the Endothelial Glycocalyx, the Elastic Properties of the Arteries and the Coronary Flow Reserve (CFR) During Oral Glucose Tolerance Test in Patients With New Onset Diabetes Mellitus and First-degree Relatives
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The investigators plan to examine 90 subjects without known diabetes a standard 75-gr oral glucose tolerance test (OGTT) will be performed. [30 first degree relatives of diabetics with normal OGTT (relatives), 30 with normal OGTT and no family history of diabetes (normals), and 30 with abnormal OGTT (diabetics) matched for age and sex].
Plasma glucose and serum insulin levels will be measured in venous blood collected at 0, 30, 60, 90 and 120min after glucose loading. At the same time intervals, the investigators will measure:
- the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
- the aortic pulse wave velocity (PWVa), central systolic blood pressure (cSBP) and augmentation index (AI) using an oscillometric method (Arteriograph,TensioMed) as markers of arterial stiffness and wave reflections
- the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg × kg-1 × min-1) for 3 minutes to assess coronary vasomotor function
- the perfusion boundary region (PBR- micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glycocalyx thickness.
In addition, the investigators will measure free fatty acids, triglycerides, glycerol, C reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2, (LP-LPA2), tumor necrosis factor (TNF-a), interleukin 6 (IL6) and interleukin 10 (IL10) propeptide of type I procollagen, (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP 9 and 2), macrophage-colony stimulating factor ( MCSF).
The investigators will measure insulin resistance a) after fasting, using homeostatic model assessment (HOMA) and hepatic insulin sensitivity (HIS) b) during oral glucose tolerance test (OGTT) using Matsuda index and insulin sensitivity index (ISI). The investigators will categorize patients in those with normal (<140 mg/dl at 120 min) and those with abnormal OGTT (>200mg/dl at 120min).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Attiki
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Athens, Attiki, Grecia, 12462
- ''Attikon'' University General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- subjects without known diabetes
- first degree relatives of diabetics
Exclusion Criteria:
- coronary or valvular heart disease
- congestive heart failure
- peripheral vascular disease
- liver or kidney failure
- history of alcohol or drug abuse
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Controls
Subjects with no family history of diabetes mellitus and normal OGTT
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Relatives
First-degree relatives of patients with diabetes mellitus and normal OGTT
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Diabetics
Subjects with abnormal OGTT
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Differences of vascular function at baseline and during OGTT among the 3 groups.
Lasso di tempo: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
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Differences of pulse wave velocity, augmentation index and central aortic blood pressure at baseline and during OGTT among the 3 groups.
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Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
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Differences of endothelial function at baseline and during OGTT among the 3 groups.
Lasso di tempo: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
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Differences of coronary flow reserve and endothelial glycocalyx thickness at baseline and during OGTT among the 3 groups.
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Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Insulin resistance and arterial stiffness
Lasso di tempo: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
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Association of insulin resistance with changes of pulse wave velocity, augmentation index and central aortic blood pressure during OGTT
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Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
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Insulin resistance and endothelial function
Lasso di tempo: Baseline, 30 min, 60 min, 90 min,120 min of OGTT
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Association of insulin resistance with changes of coronary flow reserve and endothelial glycocalyx during OGTT
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Baseline, 30 min, 60 min, 90 min,120 min of OGTT
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Vaia Lambadiari, MD, 2nd Department of Internal Medicine , University of Athens, Greece
- Investigatore principale: Charalambos Koukoulis, MD, 2nd Cardiology Department, University of Athens, Greece
- Investigatore principale: Maria Varoudi, MD, 2nd Cardiology Department, University of Athens, Greece
- Investigatore principale: Vlasios Tritakis, MD, 2nd Cardiology Department, University of Athens, Greece
- Investigatore principale: Helen Triantafyllidi, MD, 2nd Cardiology Department, University of Athens, Greece
Pubblicazioni e link utili
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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
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K-DM-ATTIKON
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