Status:
UNKNOWN
Evaluation and Intervention of Cognitive Function in Patients With Diabetes Mellitus.
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Type2 Diabetes
Eligibility:
All Genders
40-60 years
Phase:
EARLY_PHASE1
Brief Summary
This study is a randomized controlled, single-center study of the cognitive function of diabetic patients in the Department of Endocrinology in our hospital. Through the collection of clinical data du...
Detailed Description
A large amount of evidence indicates that diabetes (DM) is related to mild cognitive impairment (MCI), vascular dementia and Alzheimer disease (AD). Biological, clinical and epidemiological data all s...
Eligibility Criteria
Inclusion
- some patients with type 2 diabetes were observed and studied:
- type 2 diabetes was diagnosed according to the 1999 WHO standard and the course of disease was less than 1 year;
- no hypoglycemic drugs were used or stopped for more than 12 weeks;
- 40-60 years old (including both ends);
- able to understand the procedures and methods of this study, willing to strictly abide by the clinical trial plan to complete the trial, and voluntarily signed the informed consent form.
- healthy controls were age, sex and weight matching:
- 40-60 years old (including both ends);
- normal blood glucose: fasting blood glucose\<6.1mmol/l, postprandial 2-hour blood glucose \<7.8mmol /l;
- able to understand the procedures and methods of this study, willing to strictly abide by the clinical trial plan to complete this trial, and voluntarily signed the informed consent form.
Exclusion
- pregnancy or lactation;
- acute complications (including DKA, hypertonic coma) not corrected;
- history of cerebral hemorrhage and stroke;
- other neurological and mental disorders that clearly affect cognitive function, such as anxiety, depression, AD, PD;
- the New York Heart Association (NYHA) defines congestive heart failure as Class III or IV;
- active liver disease and / or obvious abnormal liver function, defined as AST \>2.5 times the normal upper limit and / or ALT\>2.5 times the normal upper limit and / or total bilirubin \> 1.5 times the normal upper limit;
- moderate and severe renal insufficiency \[using CKD-EPI formula to calculate eGFR\<60ml/ (min\*1.73m2)\];
- malignant tumor has not been cured;
- AD family history (first-degree relatives such as parents, siblings, children, etc.). (10) Alcohol or drug abuse within 3 months, which, according to the researchers, may affect the participants' participation in the study or the status of the subjects, resulting in drug use or compliance during the trial (alcohol abuse is defined as alcohol intake of more than 15g a day for women and more than 25g for men (15g alcohol equals 450mL beer, 150mL wine or 50mL low spirits), more than twice a week);
- long-term intravenous administration, oral administration and intra-articular administration of corticosteroids for more than 7 days within 2 months before screening;
- patients with thyroid dysfunction with unstable treatment dose within 3 months (such as thiourea, thyroid hormones);
- severe trauma or infection that may affect blood glucose control within 1 month;
- patients with severe systemic diseases who were judged by the researchers to be unsuitable for enrollment;
- conditions that other researchers considered inappropriate to participate in this clinical trial.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05262257
Start Date
April 1 2022
End Date
December 30 2023
Last Update
March 16 2022
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