- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04897815
Fasting and Postprandial Cerebral Blood Flow in Type 2 Diabetic Patients
15. juni 2021 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
40
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
25 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with type 2 diabetes mellitus and healthy volunteers
Beskrivelse
Inclusion Criteria:
Trial group
- Study time: June 1, 2021, to January 1, 2022;
- Study site: The First Affiliated Hospital of Shandong First Medical University;
- 25-65 years old (including upper and lower limits), male or female;
- Meeting the diagnostic criteria of type 2 diabetes (according to 1997 WHO's diagnostic criteria for type 2 diabetes);
- Fasting blood glucose < 10 mmol/L;
- HbA1c ≤ 11.0%.
Control group
- Study time: June 1, 2021, to January 1, 2022;
- Study site: The First Affiliated Hospital of Shandong First Medical University;
- Relatively healthy people without type 2 diabetes mellitus diagnosis;
- Participants whose sex and age and BMI matched with the experimental group.
Exclusion Criteria:
Trial group and Control group
- Participants with diabetic retinopathy;
- Participants with diabetic neuropathy;
- Participants with diabetic nephropathy;
- Participants have unilateral or bilateral carotid plaque;
- Participants have a history of cardio-cerebrovascular disease;
- Participants have a history of respiratory disease;
- Participants complicated with hypertension;
- Participants complicated with hyperlipidemia;
- Participants have a smoking history (including previous smoking history);
- Participants complicated with malignant tumor.
- Participants are currently taking anticoagulants or vasodilators;
- Participants do not sign a written informed consent form.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes of cerebral blood flow on fasting and 1 hour postprandial.
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The relationship between the fluctuation of blood glucose and the change of cerebral blood flow.
Tidsramme: Data of all participants will be collected within 6 months.
|
Data of all participants will be collected within 6 months.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juli 2021
Primær færdiggørelse (Forventet)
1. december 2021
Studieafslutning (Forventet)
1. januar 2022
Datoer for studieregistrering
Først indsendt
20. maj 2021
Først indsendt, der opfyldte QC-kriterier
20. maj 2021
Først opslået (Faktiske)
24. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LJB-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Cerebral blodgennemstrømning
-
University of California, San DiegoAfsluttetHudtryk under Blood Draw-tourniquetsForenede Stater
-
Başakşehir Çam & Sakura City HospitalRekrutteringLavt flow anæstesi | High Flow anæstesiKalkun
-
John M. StulakAfsluttet
-
Ankara City Hospital BilkentIkke rekrutterer endnuRobotkirurgi | Lavt flow anæstesi | Normal flow anæstesiKalkun
-
Ataturk UniversityAfsluttetVurdering af lungedynamik og åndedrætsfunktioner i minimal flow-anæstesi: en prospektiv undersøgelseOverholdelse, patient | Lungefunktionstest | Minimal Flow Anæstesi | Medium Flow Anæstesi | Peak Inspiratuar PressureKalkun
-
University of PennsylvaniaAfsluttet
-
Hospital de Clinicas de Porto AlegreUniversity of BrasiliaAfsluttetNedsat vaskulær flowBrasilien
-
Medical University of ViennaAfsluttet
-
Lashmi VenkatraghavanUniversity Health Network, TorontoAfsluttet
-
Rush University Medical CenterPeople's Hospital of Xinjiang Uygur Autonomous RegionAfsluttetHigh Flow næsekanyleKina