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Fasting and Postprandial Cerebral Blood Flow in Type 2 Diabetic Patients

15 juni 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with type 2 diabetes mellitus and healthy volunteers

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Groep / Cohort

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Changes of cerebral blood flow on fasting and 1 hour postprandial. Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
The relationship between the fluctuation of blood glucose and the change of cerebral blood flow. Tijdsspanne: Data of all participants will be collected within 6 months.	Data of all participants will be collected within 6 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Qianfoshan Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 juli 2021

Primaire voltooiing (Verwacht)

1 december 2021

Studie voltooiing (Verwacht)

1 januari 2022

Studieregistratiedata

Eerst ingediend

20 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria