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

Sponsor

Third Military Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04304261

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Cognitive Functions Confusion	Drug: Dapagliflozin Drug: Metformin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dapagliflozin 12 weeks of Dapagliflozin(10mg/day) treatment, randomly	Drug: Dapagliflozin Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Dapagliflozin(10mg/day) treatment
Experimental: Metformin 12 weeks of Metformin (1500-2000mg/day) treatment, randomly	Drug: Metformin Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Metformin (1500-2000mg/day) treatment

Arm

Intervention/Treatment

Experimental: Dapagliflozin

12 weeks of Dapagliflozin(10mg/day) treatment, randomly

Drug: Dapagliflozin

Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Dapagliflozin(10mg/day) treatment

Experimental: Metformin

12 weeks of Metformin (1500-2000mg/day) treatment, randomly

Drug: Metformin

Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Metformin (1500-2000mg/day) treatment

Outcome Measures

Primary Outcome Measures

Changes of cognitive function assessed by cognitive function scale after 12 weeks [Baseline,12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Early onset type 2 diabetes within 3 months 7%<HbA1c<10%

Exclusion Criteria:

Type 2 diabetes with acute diabetic complications. Type1 diabetes. Other diseases affecting cognitive function (congenital dementia, brain trauma, severe heartdysfunction,severekidneydysfunction,severelungdysfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.); Alcohol abuse,mental illness and psychoactive substance abuse History of thyroid disease Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

History of depression, schizophrenia or dementia. History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.

History of parkinson's diseases, head injury,toxicencephacopathy,epilepsy. Hypohepatia (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, mental disorders, alcohol or medicine addiction.

Fertile woman without contraceptives. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

Allergic to or have contraindication to the intervention drugs.