Fasting and Postprandial Cerebral Blood Flow in Type 2 Diabetic Patients

NCT04897815 | Unknown

• 1 other identifier: LJB-01
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Cerebral Blood Flow

Keywords

Type 2 Diabetes Mellitus; Cerebral blood flow

Outcome Measures

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.

  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.

  Data of all participants will be collected within 6 months.

Study Arms (2)

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.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes mellitus and healthy volunteers

You may qualify if:

• Trial group
• Study time: June 1, 2021, to January 1, 2022;
• Study site: The First Affiliated Hospital of Shandong First Medical University;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lin Liao, Doctor

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Liao, Doctor

CONTACT

18354117713; liaolin@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 24, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06