Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)

Sponsor
Third Military Medical University
Study ID
NCT04304261
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    12 weeks of Canagliflozin(100mg/day) treatment
  • Sitagliptin — DRUG
    12 weeks of Sitagliptin (100mg/day) treatment

Study Details

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 seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied. 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.

Key Dates

Start date
Jul 1, 2021
Status verified
May 2024
Primary completion
Dec 1, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin
    12 weeks of Canagliflozin(100mg/day) treatment, randomly
  • Experimental: Sitagliptin
    12 weeks of Sitagliptin (100mg/day) treatment, randomly

Primary Outcome Measure

Changes of cognitive function assessed by cognitive function scale [ Time Frame: 12 weeks ]

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