Type 1 Diabetes Clinical Trial
— ITOPOSOfficial title:
Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | CH sud francilien | Corbeil Essonnes |
Lead Sponsor | Collaborator |
---|---|
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assay of isoprostane-F2, an indicator of lipid peroxidase derivative production, in the 24 hour urine | T0, T3 months, T6 months | No |
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