Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)
NCT ID: NCT04304261
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2021-07-01
2024-04-30
Brief Summary
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Sodium-glucose transporter-2 (SGLT-2) inhibitors, which lower serum glucose by inhibiting SGLT2-mediated glucose reabsorption in renal proximal tubules, could be neuroprotective. It was recently reported that the SGLT-2 inhibitor improved cognitive function and ameliorated oxidative stress via attenuating mitochondrial dysfunction, insulin resistance, inflammation, and apoptosis in mice or HFD-induced obese rats, that means SGLT-2 inhibitor may provide neuroprotection in the diabetic brain. Hence, Invokana (Canagliflozin) might act as a potent dual inhibitor of AChE and SGLT2. Since the development of diabetes is associated with AD, the design of new AChE inhibitors based on antidiabetic drug scaffolds would be particularly beneficial. Moreover, the present computational study reveals that Invokana (Canagliflozin) is expected to form the basis of a future dual therapy against diabetes associated neurological disorders.
The overall goal of this study is to explore the effects of SGLT2 inhibitor on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Canagliflozin
12 weeks of Canagliflozin(100mg/day) treatment, randomly
Canagliflozin
12 weeks of Canagliflozin(100mg/day) treatment
Sitagliptin
12 weeks of Sitagliptin (100mg/day) treatment, randomly
Sitagliptin
12 weeks of Sitagliptin (100mg/day) treatment
Interventions
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Canagliflozin
12 weeks of Canagliflozin(100mg/day) treatment
Sitagliptin
12 weeks of Sitagliptin (100mg/day) treatment
Eligibility Criteria
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Inclusion Criteria
* 7%\<HbA1c\<10%
Exclusion Criteria
* 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.
40 Years
70 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Zhiming Zhu
Director of the Department of Hypertension & Endocrinology, Daping Hospital
Locations
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Zhiming Zhu
Chongqing, Chongqing Municipality, China
Countries
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Other Identifiers
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ESCDP
Identifier Type: -
Identifier Source: org_study_id
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