Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention

Type 1 Diabetes Clinical Trial

— ITOPOS  

Official title:

Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934336
• Other study ID #: 2007-A01036-47
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: August 5, 2015
• Start date: November 2008
• Est. completion date: April 2011

Study information

• Verified date: February 2011
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Therapeutic and preventive strategies
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).
• Therapeutic and preventive strategies
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).

Locations

Country	Name	City	State
France	CH sud francilien	Corbeil Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

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