Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Canagliflozin group, Sitagliptin, Acarbose.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus, Cognitive Impairment. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment- a Prospective, Randomized, Single-blind, Controlled, Single-center, Head-to-head Clinical Cohort Study
Overview
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.
Detailed description
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients. Cognitive impairment mainly includes two stages: mild cognitive impairment (MCI) and dementia. Early detection of diabetic patients with MCI and effective intervention measures to prevent and delay the onset of dementia have important clinical value and social significance. With the development of imaging technology, especially fMRI changes in local blood flow and metabolic activities of the brain can be displayed before changes in brain structure. The central insulin resistance status observed by fMRI may serve as an alternative endpoint for assessing cognitive function. SGLT2i has been shown to significantly improve insulin resistance in the central nervous system in previous basic and clinical studies. However, up to now, no head-to-head clinical studies have been reported on SGLT2i and other antidiabetic drugs in patients with MCI.
Based on the above research background, we hypothesize that canagliflozin, as a clinically commonly used SGLT2i, it may improve cognitive function in patients with type 2 diabetes mellitus and MCI by improving insulin resistance in the central nervous system.
Interventions
- Drug Canagliflozin group
Canagliflozin,100mg once daily, orally, for 6 months - Drug Sitagliptin
Sitagliptin,100mg once daily, orally, for 6 months - Drug Acarbose
Acarbose,100mg three times daily, orally, for 6 months
Primary outcome measures
- the changes in cerebral blood flow shown by fMRI [Time frame: 6 months]
Secondary outcome measures (7)
- Montreal Cognitive Assessment Scale (Moca scale) [Time frame: 6 months]
- body composition [Time frame: 6 months]
- grip strength [Time frame: 6 months]
- glycated hemoglobin [Time frame: 6 months]
- insulin [Time frame: 6 months]
- C-peptide [Time frame: 6 months]
- blood glucose [Time frame: 6 months]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University affiliated Huadong Hospital — Shanghai
Identifiers
NCT: NCT07711171 · 2022XD020