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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic and preventive strategies
Therapeutic and preventive strategies
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CH sud francilien

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

preprandial injection

post-prandial injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assay of isoprostane-F2, an indicator of lipid peroxidase derivative production, in the 24 hour urine

Secondary Outcome Measures

Full Information

First Posted
July 7, 2009
Last Updated
August 5, 2015
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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1. Study Identification

Unique Protocol Identification Number
NCT00934336
Brief Title
Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention
Acronym
ITOPOS
Official Title
Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preprandial injection
Arm Type
Experimental
Arm Description
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.
Arm Title
post-prandial injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic and preventive strategies
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Therapeutic and preventive strategies
Intervention Description
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).
Primary Outcome Measure Information:
Title
Assay of isoprostane-F2, an indicator of lipid peroxidase derivative production, in the 24 hour urine
Time Frame
T0, T3 months, T6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FEVE Bruno, MD PH
Organizational Affiliation
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
CHARPENTIER Guillaume, PH
Organizational Affiliation
CH Sud Francilien
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH sud francilien
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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