Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment
Recruiting · NCT07711171 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients, and early intervention is of great significance. Central nervous system insulin resistance plays a key role in the pathogenesis of cognitive dysfunction in diabetic patients. Central insulin resistance observed by functional magnetic resonance imaging (fMRI), may serve as an alternative endpoint for assessing cognitive function. Sodium glucose cotransporter 2 inhibitor (SGLT2i) may improve cognitive impairment by improving central insulin resistance.
Who can take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- age: 40-75 years old;
- HbA1c: 7.0 - 10.0%;
- Moca scale total score between 20-26 (duration of education is more than 10 years) or total score between 20 and 25 (duration of education is less than 10 years);
- sign informed consent;
Exclusion criteria
- left-handedness;
- duration of diabetes is less than 6 years;
- inability to complete central nervous system magnetic resonance imaging;
- alcohol or drug addiction history;
- use of other oral hypoglycemic drugs within 90 days prior to enrollment except for metformin;
- Family or past history of neurological or psychiatric disorders, pancreatitis, medullary thyroid cancer and multiple endocrine adenomatosis;
- History of recurrent urinary tract infection and malignant tumor;
- History of severe gastrointestinal diseases and gastroenteric surgery;
- Pregnancy/lactation status;
- Abnormal liver function (liver enzyme index is more than 2.5 times the upper limit of the reference range) or abnormal kidney function (estimated glomerular filtration rate is less than 45ml/min); Type 1 diabetes; other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, which are likely to cause loss of follow-up, according to the judgment of the researchers;
Where it is running
1 location listed.
- Fudan University affiliated Huadong Hospital - Shanghai, Shanghai Municipality, China