Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      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).
    


Intervention name(s): Therapeutic and preventive strategies; Therapeutic and preventive strategies
Intervention type(s): Other; Other
Intervention description(s): 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).; 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).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention