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Status unknownNCT04897815Updated Jun 16, 2021

Fasting and Postprandial Cerebral Blood Flow in Type 2 Diabetic Patients

An observational study in Type 2 Diabetes Mellitus and Cerebral Blood Flow, sponsored by Qianfoshan Hospital. Status unknown. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-16.

Sponsored by Qianfoshan Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
25 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Cerebral Blood Flow

Keywords

  • Type 2 Diabetes Mellitus
  • Cerebral blood flow
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 40 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with type 2 diabetes mellitus and healthy volunteers

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Changes of cerebral blood flow on fasting and 1 hour postprandial.

    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.

    Time frame: Data for each participant will be collected within 3 days.

Secondary outcomes

  1. The relationship between the fluctuation of blood glucose and the change of cerebral blood flow.

    Time frame: Data of all participants will be collected within 6 months.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04897815
Lead sponsor
Qianfoshan Hospital
Responsible party
Lili Cao (Professor, Qianfoshan Hospital) — Principal investigator
First posted
May 24, 2021
Start date
Jul 1, 2021 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Jun 16, 2021

Study contacts

Lin Liao, Doctor
Contact
liaolin@sdu.edu.cn
18354117713
Lin Liao, Doctor
principal investigator · The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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