Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Fasting and Postprandial Cerebral Blood Flow in Type 2 Diabetic Patients

15 juin 2021 mis à jour par: Lili Cao, Qianfoshan Hospital

The purpose of this study is to explore the changes of fasting and postprandial cerebral blood flow in patients with type 2 diabetes mellitus. Some studies have proved that non-fasting blood glucose concentration is an independent predictor of ischemic stroke and lacunar infarction. At present, there are differences in cerebral blood flow velocity between diabetic patients and healthy controls. Therefore, it is of certain significance to explore the changes of fasting and postprandial cerebral blood flow in patients with type 2 diabetes mellitus.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

In China, due to the aging population and the increase in obesity, the incidence of diabetes is on the rise. Diabetes is the main independent risk factor for cerebrovascular diseases, especially ischemic stroke. Some studies have proved that non-fasting blood glucose concentration is an independent predictor of ischemic stroke and lacunar infarction. Transcranial Doppler (TCD) can evaluate intracranial blood flow patterns real-time and reliably, and provide information about cerebral hemodynamics, cerebrovascular reactivity and various pathological changes. At present, there are some differences in the study of cerebral blood flow velocity in diabetic patients. The purpose of our study is to determine the changes of cerebral blood flow on an empty stomach and 1 hour after meal in patients with type 2 diabetes. In this study, 20 patients with type 2 diabetes mellitus will be selected as the experimental group. 20 healthy volunteers whose sex and age and BMI matched with the experimental group will be selected as the control group. Fasting blood glucose and TCD will be measured in the two groups, and the data of mean flow velocity (Vm), Gosling's pulsatility index (PI) and cerebrovascular reactivity of cerebral artery will be obtained. One hour after drinking 300ml lukewarm water which has dissolved 75g glucose powder, the blood glucose will be detected again and TCD examination will be performed again. Finally, the data will be collected for statistical analysis.

Type d'étude

Observationnel

Inscription (Anticipé)

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

25 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients with type 2 diabetes mellitus and healthy volunteers

La description

Inclusion Criteria:

Trial group
1. Study time: June 1, 2021, to January 1, 2022;
2. Study site: The First Affiliated Hospital of Shandong First Medical University;
3. 25-65 years old (including upper and lower limits), male or female;
4. Meeting the diagnostic criteria of type 2 diabetes (according to 1997 WHO's diagnostic criteria for type 2 diabetes);
5. Fasting blood glucose < 10 mmol/L;
6. HbA1c ≤ 11.0%.
Control group
1. Study time: June 1, 2021, to January 1, 2022;
2. Study site: The First Affiliated Hospital of Shandong First Medical University;
3. Relatively healthy people without type 2 diabetes mellitus diagnosis;
4. Participants whose sex and age and BMI matched with the experimental group.

Exclusion Criteria:

Trial group and Control group
1. Participants with diabetic retinopathy;
2. Participants with diabetic neuropathy;
3. Participants with diabetic nephropathy;
4. Participants have unilateral or bilateral carotid plaque;
5. Participants have a history of cardio-cerebrovascular disease;
6. Participants have a history of respiratory disease;
7. Participants complicated with hypertension;
8. Participants complicated with hyperlipidemia;
9. Participants have a smoking history (including previous smoking history);
10. Participants complicated with malignant tumor.
11. Participants are currently taking anticoagulants or vasodilators;
12. Participants do not sign a written informed consent form.

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

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
20 patients with type 2 diabetes mellitus Fasting blood glucose and TCD will be measured in 20 patients with type 2 diabetes mellitus, and the data of Vm, PI and cerebrovascular reactivity of cerebral artery will be obtained. One hour after drinking 300ml lukewarm water which has dissolved 75g glucose powder, the blood glucose will be detected again and TCD examination will be performed again.
20 healthy volunteers whose sex and age and BMI matched with the experimental group Fasting blood glucose and TCD will be measured in healthy control group, and the data of Vm, PI and cerebrovascular reactivity of cerebral artery will be obtained. One hour after drinking 300ml lukewarm water which has dissolved 75g glucose powder, the blood glucose will be detected again and TCD examination will be performed again.

Groupe / Cohorte

20 patients with type 2 diabetes mellitus

Fasting blood glucose and TCD will be measured in 20 patients with type 2 diabetes mellitus, and the data of Vm, PI and cerebrovascular reactivity of cerebral artery will be obtained. One hour after drinking 300ml lukewarm water which has dissolved 75g glucose powder, the blood glucose will be detected again and TCD examination will be performed again.

20 healthy volunteers whose sex and age and BMI matched with the experimental group

Fasting blood glucose and TCD will be measured in healthy control group, and the data of Vm, PI and cerebrovascular reactivity of cerebral artery will be obtained. One hour after drinking 300ml lukewarm water which has dissolved 75g glucose powder, the blood glucose will be detected again and TCD examination will be performed again.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Changes of cerebral blood flow on fasting and 1 hour postprandial. Délai: Data for each participant will be collected within 3 days.	Detect changes in cerebral blood flow after fasting and 1 hour after meal by TCD, including changes in average cerebral blood flow velocity, PI, and cerebrovascular reactivity.	Data for each participant will be collected within 3 days.

Mesures de résultats secondaires

Mesure des résultats	Délai
The relationship between the fluctuation of blood glucose and the change of cerebral blood flow. Délai: Data of all participants will be collected within 6 months.	Data of all participants will be collected within 6 months.

Collaborateurs et enquêteurs

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

Parrainer

Qianfoshan Hospital

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 (Anticipé)

1 juillet 2021

Achèvement primaire (Anticipé)

1 décembre 2021

Achèvement de l'étude (Anticipé)

1 janvier 2022

Dates d'inscription aux études

Première soumission

20 mai 2021

Première soumission répondant aux critères de contrôle qualité