Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention (ITOPOS)
The aim of this study is to determine whether postprandial hyperglycaemia plays an important role in oxidative stress phenomena and influences their harmful effects on the arterial wall.
25 type 1 diabetic patients practicing FIT and with an HbA1c value of 8 percent or less at the beginning of the study will be recruited. The 25 control subjects will be recruited after the patients, so that they can be paired by age and sex.
Patients will be randomized via an alternative cross over study design for 2 periods of 3 months, i.e. preprandial or postprandial injection of an ultra fast acting analog. During the 6 months of the study, slow acting analog doses will be adjusted on the basis of basal glycaemia values. The fast acting analog doses will be adjusted on the basis of an optimized algorithm available on each patient's PDA phone electronic diary.
Blood and urine samples will be collected at M0, M3 and M6 to evaluate the stress oxidant grade and its consequence on atherogenesis:
Oxidative Stress evaluation: plasma parameters (lipid peroxide derivatives, semicarbazide sensitive oxidase amine activity), erythrocyte and leukocyte cell parameters (reduced and oxidised glutathion, dismutase superoxide activity (SOD) Cu and Mn dependent, glutathion peroxidase, and catalase), urinary parameters (isoprostane F2) Evaluation of consequences of oxidative stress on atherogenesis processes: inflammatory parameters (CRP, TNFa, IL 6), adhesion molecules (VCAM 1, ICAM 1, P selectine), adipokines (leptine, resistine, adiponectine), coagulation factors (PAI 1), platelet and endothelial microparticles, The pre and postprandial glycaemic stability of each patient will be monitored using PDA phone systems, and HbA1c will be measured at M0, M3 and M6.
Expected results and outcomes:
It is important to know if, in patients with comparable glycaemic stability, these two insulin treatment regimens are associated with significant differences in oxidative stress and anti oxidant defenses.
These results may help us to define a postprandial insulin treatment regimen (which is more flexible as regards meals) or a preprandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Corbeil Essonnes, Frankrijk, 91106
- Ch Sud Francilien
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Type 1 Diabetes
- treaties by basal / bolus with a ultra rapid analogue or a pump with a ultra rapid analogue
- Adults between 18 and 50 years old
- Patients practicing FIT
- Written informed consent obtained prior to enrollment in the study
- HbA1c ≤ 8%
Exclusion Criteria:
- Diabetes other than DT1
- Complications: coronary or peripheral arteriopathy
- Pathologies being able to interfere with the study: HTA, dyslipidemia, nicotinism, inflammatory , cancerous pathology…
- Psychiatric pathologies incompatible with the study
- Pregnancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: preprandial injection
pre-prandial injection of an ultra-fast-acting analog during 3 months, then post-prandial injection of an ultra-fast-acting analog during 3 other months.
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These results may help us to define a post prandial insulin treatment regimen (which is more flexible as regards meals) or a pre prandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).
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Experimenteel: post-prandial injection
post-prandial injection of an ultra-fast-acting analog during 3 months then pre-prandial injection of an ultra-fast-acting analog during 3 other months.
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These results may help us to define a post prandial insulin treatment regimen (which is more flexible as regards meals) or a pre prandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Assay of isoprostane-F2, an indicator of lipid peroxidase derivative production, in the 24 hour urine
Tijdsspanne: T0, T3 months, T6 months
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T0, T3 months, T6 months
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: FEVE Bruno, MD PH, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Hoofdonderzoeker: CHARPENTIER Guillaume, PH, Ch Sud Francilien
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2007-A01036-47
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