Clinical efficacy and safety study of SGLT-2 inhibitor dagliflozin to improve cognitive dysfunction in combination with type 2 diabetes

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200067020

Enrollment

Unknown

Registered

2022-12-23

Start date

2022-06-08

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Dapagliflozin group:Oral dapagliflozin

The control group:no

Eligibility

Sex/Gender

All

Age

55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 55-75 years old; 2. Use one or more hypoglycemic drugs (excluding the use of SGLT2 inhibitors or GLP-1 receptor agonists) with poorly controlled type 2 diabetes mellitus; 3. HbA1c 7.0 ~ 11%, FBS <= 15mmol/L, BMI 18~35 kg/m2; 4. And mild cognitive impairment (MCI diagnostic criteria are based on the Petorsen scheme: that is, the main complaint is memory impairment, and there is evidence of memory impairment inconsistent with age and education level; General cognitive function is normal; does not meet the diagnostic criteria for dementia; MoCA < 26 points; MMSE score 24-27 points, illiterate 15-19 points, primary school level 18-22 points, middle school or above 22-27 points).

Exclusion criteria

Exclusion criteria: 1. Cardiac insufficiency, liver and kidney insufficiency (serum creatinine >= 136 µmol/L (male) and 124 µmol/L (female), transaminases 2.5 times higher than the upper limit of normal); 2. Already using SGLT2 inhibitors or GLP-1 receptors agonist patients; 3. Urinary or reproductive tract infections; 4. Tumors and chronic infections, psychiatric patients, blood and immune system diseases, especially those who need to take hormones; 5. Other diseases that affect cognitive function; 6. Acute and chronic severe diabetic complications/comorbidities, such as stroke, etc.

Design outcomes

Primary

Measure	Time frame
Minimum Mental State Examination;Montreal Cognitive Assessment;functional magnetic resonance imaging;	—

Secondary

Measure	Time frame
Human serum Aß1-40;Human serum Aß1-42;Glycosylated hemoglobin;Fast blood glucouse;2-hour post-meal blood glucose;blood lipid;hepatic function;renal function;	—

Countries

China

Contacts

Public ContactZhong Xing

The Second Affiliated Hospital of Anhui Medical Sciences

Zhongxing761@163.com+86 18905692292

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026