Type 1 DiabetesITOPOSNCT00934336
Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention
A study testing Therapeutic and preventive strategies in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Therapeutic and preventive strategies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Type 1 Diabetes
- Being tested
- Therapeutic and preventive strategies
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic and preventive strategiesOther
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 strategiesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| preprandial injection | Experimental | 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. Receives: Other: Therapeutic and preventive strategies |
| post-prandial injection | Experimental | 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. Receives: Other: Therapeutic and preventive strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assay of isoprostane-F2, an indicator of lipid peroxidase derivative production, in the 24 hour urine
Measured: T0, T3 months, T6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FEVE Bruno, MD PH, Study chair, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteCHARPENTIER Guillaume, PH, Principal investigator, CH Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934336
- Sponsor's protocol ID
- 2007-A01036-47
- Acronym
- ITOPOS
- Status last verified
- Feb 2011
- First submitted
- 7 Jul 2009
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention
- ClinicalTrials.gov ID
- NCT00934336
- Acronym / sponsor ID
- ITOPOS / 2007-A01036-47
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preprandial injection | Experimental | Other: Therapeutic and preventive strategiespre-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 | Experimental | Other: Therapeutic and preventive strategiespost-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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic and preventive strategiesThese 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). | Other | preprandial injection |
| Therapeutic and preventive strategiesThese 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). | Other | post-prandial injection |
Primary outcome
Assay of isoprostane-F2, an indicator of lipid peroxidase derivative production, in the 24 hour urine
Time frame: T0, T3 months, T6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FEVE Bruno, MD PH study chair
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
CHARPENTIER Guillaume, PH principal investigator
CH Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic and preventive strategies in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assay of isoprostane-F2, an indicator of lipid peroxidase derivative production, in the 24 hour urine (time frame: T0, T3 months, T6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.