NCT07711171 Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment
| NCT ID | NCT07711171 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fudan University |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-08-19 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07711171 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07711171 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07711171 currently recruiting?
Yes, NCT07711171 is actively recruiting participants. Contact the research team at lubinfd@126.com for enrollment information.
Where is the NCT07711171 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07711171 clinical trial?
NCT07711171 is sponsored by Fudan University. The trial plans to enroll 60 participants.
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