Status:
COMPLETED
Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)
Lead Sponsor:
Third Military Medical University
Conditions:
Diabetes Mellitus, Type 2
Cognitive Functions Confusion
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief Summary
Type 2 diabetes is associated with diabetic cognopathy, the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population. Cognitive impairment seriousl...
Eligibility Criteria
Inclusion
- Newly onset type 2 diabetes within 3 months
- 7%\<HbA1c\<10%
Exclusion
- Type 2 diabetes with acute diabetic complications.
- Type1 diabetes.
- Thyroid dysfuncition.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- Hepatic insufficiency (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- Acute infections, tumor, severe arrhythmia.
- Alcohol or medicine addiction, psychoactive substance abuse.
- Other diseases affecting cognitive function (congenital dementia, brain trauma, parkinson's diseases, toxicencephacopathy,epilepsy, mental disorders, severe lungdy sfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.)
- Fertile woman without contraceptives.
- Allergic to or have contraindication to the intervention drugs.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04304261
Start Date
July 1 2021
End Date
April 30 2024
Last Update
May 30 2024
Active Locations (1)
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1
Zhiming Zhu
Chongqing, Chongqing Municipality, China, 400042