Trouver des essais cliniques
Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
Code de protocole Servier:
CL1-RTCMP-001
Sponsor:
Institut de Recherches Internationales Servier
Identifiant Clinicaltrials.gov:
NCT04744636
Numéro EudraCT:
2017-000045-42
Trouver un site de recrutement
Comment participer à cette étude
Si vous pensez être éligible pour cette étude (voir
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Nom:
Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone:
+33 1 55 72 60 00
L'étude a 1 centre
Description de l'étude
The present interventional study will be performed in 3 groups of healthy volunteers of different ages and in type 2 diabetic patients without an investigational medicinal product administrated.
Titre officiel: Target Involvement and Exploratory Biomarkers Investigations in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
Indications
Type 2 Diabetes Mellitus
Interventions / Traitements
Le ou les traitements administrés aux participants à l'étude.
- Other
Autres numéros d'identification
Autres numéros d'identification sous lesquels l'étude peut être connue.
- CL1-RTCMP-001
Critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Age éligible pour l’étude
18 ans à 70 ans
(Adulte, Adulte plus âgé)
Sexe
Homme/FemmeAccepte les volontaires en bonne santé
Oui- Healthy volunteers:
- * Age [18 -30], [50-59] and [60-70] years
- * Male and female healthy volunteers, except with skin types 5 and 6
- * Body weight ≥ 50 kg and BMI between [18.0 -28.0] kg/m^2 inclusive
- * Non or ex-smokers (defined as someone who completely stopped smoking for at least 1 month before the beginning of this study)
- * No clinically relevant findings in the medical history and physical examination, especially with regards to cardiovascular system, lung, liver and renal function
- * Normal blood and urine laboratory tests
- Patients with type 2 diabetes (T2D) mellitus:
- * Male and female patients, except with skin types 5 and 6
- * Age [50 - 70] years
- * BMI ≤35 kg/m2
- * T2D patients (according to American Diabetes Association (ADA) criteria i.e. HbA1c > 6.5% or fasting plasma glucose > 126 mg/dL (7.00 mmol/L) or 2-hour glucose ≥ 200mg/dL (11.1mmol/L) after 75g oral glucose or glucose ≥200mg/dL (11.1mmol/L) at any time on two separate occasions (historic values and/or at selection)
- * Currently treated with Standards of Medical Care in T2D at stable doses for at least 3 months
- * Antihypertensive drugs allowed except beta-blockers and calcium antagonists
- * Non or ex-smokers (defined as someone who completely stopped smoking for at least 1 month before the beginning of this study)
- Healthy volunteers:
- * Unlikely to co-operate in the study,
- * Participation in another interventional study, including last study drug intake, at the same time or within the 3 months preceding the selection visit; participation in non-interventional registries or epidemiological studies is allowed,
- * Deprived of his freedom by administrative or court order or under guardianship,
- * History or evidence of acute or chronic abuse of alcohol consumption of> 21 alcohol units per week for males and >14 units per week for females (1 alcohol unit = 100 mL of 12% wine; = 30 mL of 40% spirits; = 250 mL of 6% beer),
- * Positive alcohol breath test,
- * Positive cotinine test,
- * Known or suspected to be drug-dependent,
- * Positive result in urinary screening for drug abuse,
- * Pregnancy, breastfeeding or lactating,
- * Regular use of prescribed and non-prescribed drugs in the last 60 days before the day of investigations into the study except hormonal contraception (e.g. pill or hormonal intrauterine device (IUD) or hormonal implants or Nuva Ring) (if applicable),
- * Any drug intake of prescribed or non-prescribed drugs including over-counter drugs (except acetaminophen), herbal remedies or nutritional supplements such as multivitamins in the 2 weeks before the day of investigations unless the investigator deems this drug intake to be irrelevant for the purpose of this study and that can be temporarily suspended,
- * Intake of dipyridamol (contraindicated with adenosine infusion)
- * Known hypersensitivity to adenosine injection,
- * Any acute or chronic illness or clinically relevant findings (i.e. liver, kidney, cardiovascular diseases) in the selection visit examinations,
- Patients with type II diabetes mellitus (T2D):
- * Unlikely to co-operate in the study,
- * Participation in another interventional study, including last study drug intake, at the same time or within the 3 months preceding the selection visit; participation in non-interventional registries or epidemiological studies is allowed,
- * Deprived of his freedom by administrative or court order or under guardianship,
- * Unwilling to allow his or her primary care practitioner to be notified of participation in the study and for information on a participant's medical history to be obtained from the general practitioner,
- * History or evidence of acute or chronic abuse of alcohol consumption of> 21 alcohol units per week for males and >14 units per week for females (1 alcohol unit = 100 mL of 12% wine; = 30 mL of 40% spirits; = 250 mL of 6% beer),
- * Positive alcohol breath test,
- * Positive cotinine test,
- * Known or suspected to be drug-dependent,
- * Positive result in urinary screening for drug abuse,
- * Pregnancy, breastfeeding or lactating,
- * Intake of dipyridamol (contraindicated with adenosine infusion)
- * Known hypersensitivity to adenosine injection,
- * Any acute or chronic illness or clinically relevant findings (i.e. liver,kidney, cardiovascular diseases) in the selection visit examinations.
Comment l'étude est-elle conçue ?
Allocation
Comment les participants sont répartis dans différents groupes. La répartition peut être aléatoire (randomisée) ou prédéterminée (non randomisée). Randomisée signifie que les participants sont répartis de manière aléatoire dans leur groupe/branche.
Modèle d'étude interventionnelle
Comment les traitements sont administrés et testés dans le cadre d'une étude.
Parallèle
Une étude parallèle compare deux groupes ou plus en même temps, chaque groupe recevant un traitement différent. Les chercheurs comparent ensuite les résultats afin de déterminer quel traitement est le plus efficace.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Autre:
Healthy volunteers aged of 18-30 years
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Other
Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2.
Then, subjects will be discharged at the end of the last investigation day (Day 2).
All the participants have received two pharmacological agents (NIMP) :
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Autre:
Healthy volunteers aged of 50-59 years
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Other
Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2.
Then, subjects will be discharged at the end of the last investigation day (Day 2).
All the participants have received two pharmacological agents (NIMP) :
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Autre:
Healthy volunteers aged of 60-70 years
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Other
Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2.
Then, subjects will be discharged at the end of the last investigation day (Day 2).
All the participants have received two pharmacological agents (NIMP) :
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Autre:
Type 2 diabetic patients aged of 50-70 years
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Other
Type 2 diabetic patients will be selected within 3 weeks before inclusion (Day 0).
The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and CFR on Day 2.
Then, subjects will be discharged at the end of the last investigation day (Day 2).
All the participants have received two pharmacological agents (NIMP):
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Mots clés
Fournis par Servier
Type 2 diabetes mellitus
Phase 1
Healthy volunteers
Clinical translational exploratory study
Target involvement
Exploratory biomarkers
Cardiovascular disease
Vascular function
Coronary flow reserve
Biopterins
Cutaneous blood flow
Autres termes
Diabetes Mellitus, Type 2
Cardiovascular Diseases