Fasting and Postprandial Cerebral Blood Flow in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Fasting and Postprandial Cerebral Blood Flow in Type 2 Diabetic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04897815
• Other study ID #: LJB-01
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: June 2021
• Source: Qianfoshan Hospital
• Contact: Lin Liao, Doctor
• Phone: 18354117713
• Email: liaolin[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Blood Flow
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data for each participant will be collected within 3 days.
Secondary	The relationship between the fluctuation of blood glucose and the change of cerebral blood flow.		Data of all participants will be collected within 6 months.