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A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

21 février 2014 mis à jour par: Eli Lilly and Company

The Effect of Postprandial Hyperglycemia on the Arterial Stiffness in Patients With Type 2 Diabetes

This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

72

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Finlande
      • Helsinki, Finlande, 00014
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

45 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  • Are diagnosed with T2DM (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
  • Have not smoked in the last 12 hours prior to the study visit.
  • Have albuminuria but normal kidney function or normal UAER [UAER < 20 micrograms per minute (mcg/min) or < 30 milligrams/24 hours (mg/24h), respectively]. Participants with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI).
  • Participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
  • Each participant must understand the nature of the study and must sign an informed consent document (ICD).

Healthy participants are eligible to be included in the study only if they meet all of the following criteria:

  • Healthy participants 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
  • Normal glucose tolerance and normal UAER (UAER between < 20 μg/min in the overnight urine collection or < 30 mg/24h in the 24-h urine collection).
  • Healthy participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
  • Each healthy participant must understand the nature of the study and must sign an ICD.

Exclusion Criteria:

Participants/healthy participants will be excluded from the study if they meet any of the following criteria:

  • Have had a cardiovascular event [stroke, myocardial infarction (MI), coronary artery procedure (by-pass surgery or angioplasty), limb amputation due to ischemia, peripheral vascular disease] or coronary heart disease confirmed by exercise test or scintigraphy.
  • Have arrhythmias.
  • Have an acute infection.
  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: T2DM, albuminuria but normal kidney function
Médicament: Lispro
Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
Autres noms:
  • Humalogue
  • LY275585
Aucune intervention: Healthy participants
Expérimental: T2DM, normal urinary albumin excretion rate (UAER)
Médicament: Lispro
Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
Autres noms:
  • Humalogue
  • LY275585

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
Délai: 30 mins (pre-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
30 mins (pre-breakfast)
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
Délai: 60 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
60 mins (post-breakfast)
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
Délai: 120 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
120 mins (post-breakfast)
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
Délai: 180 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
180 mins (post-breakfast)
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
Délai: 240 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
240 mins (post-breakfast)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Pulse Wave Amplitude (PWA)
Délai: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported.
30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
Change in Peripheral Artery Tonometry (PAT)
Délai: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)
The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported.
30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)
Change in QT Interval on Electrocardiogram (ECG)
Délai: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported.
30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
Change in Blood Glucose (BG)
Délai: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)
Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.
30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)
Change in Postprandial Pulse Wave Velocity (PWV)
Délai: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported.
30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Les enquêteurs

  • Directeur d'études: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2010

Achèvement primaire (Réel)

1 février 2013

Achèvement de l'étude (Réel)

1 février 2013

Dates d'inscription aux études

Première soumission

17 juin 2010

Première soumission répondant aux critères de contrôle qualité

8 juillet 2010

Première publication (Estimation)

12 juillet 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 avril 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 février 2014

Dernière vérification

1 février 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 13087
  • F3Z-EW-IOPT (Autre identifiant: Eli Lilly and Company)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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