Canagliflozin for Type 2 Diabetes with Mild Cognitive Impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, Phase 4 trial will compare canagliflozin to other diabetes medications (sitagliptin and acarbose) in adults aged 40–75 with type 2 diabetes and mild cognitive impairment. The study uses central nervous system insulin resistance measured by fMRI as an intermediate endpoint alongside cognitive testing. It aims to determine if canagliflozin improves cognitive function by reducing insulin resistance in the brain. The trial is conducted at Fudan University Huadong Hospital in Shanghai and is sponsored by Fudan University.

Why it matters

Who can join: the full rules

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's running

• Fudan University affiliated Huadong Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Bin Lu, doctor
• Email: lubinfd@126.com
• Phone: 18121186716

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.