Cognitive Disorders with Diabetes
Conditions
Interventions
Group C:Metformin+Insulin
Group F:Pioglitazone+Metformin+Insulin
Group E:Insulin
Group D:Pioglitazone+Insulin
Group B:Pioglitazone+Insulin
Sponsors
Union Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 2 diabetes; 2. Subject has mild to moderate cognitive impairment as defined by a MMSE score <=26 at screening; 3. Hachinski ischemia score <=4 at screening; 4. Brain CT or MRI scan and Neurological exam performed at screening, showing no evidence of any focal neurological changes (i.e hemiplegia, hemidysesthesia, aphasia).
Exclusion criteria
Exclusion criteria: 1. History of significant psychiatric illness such as schizophrenia or bipolar affective disorder, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment; 2. History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, head injuries, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease; 3. Evidence of the following disorders: current vitamin B12 deficiency, malignancy, positive syphilis serology, or active thyroid dysfunction (particularly that suggestive of hypothyroidism); 4. Clinically significant anemia (i.e. hemoglobin =110 beats/min. History of cardiovascular event within the last 4 months (i.e. acute coronary syndrome [myocardial infarction, unstable angina] or significant arrhythmia; intervention, percutaneous coronary intervention, or major intervention (e.g. cardiac surgery or angiography plus stenting); 7. Systolic blood pressure >=180 or 1.5 the upper limit of normal (ULN)); 10. ALT, AST, or alkaline phosphatase values >2.5 times the ULN, total bilirubin values >1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or cirrhosis, Child-Pugh Class B/C); 11. Asthma and chronic obstructive pulmonary disease. 12. History or presence of gastro-intestinal, or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition; 13. Type 2 diabetes mellitus where the subject is being treated with other than PPAR?agonist(e.g. Rosiglitazone), or an insulin secretagogue (e.g. a sulfonylurea); 14. A history of allergic reaction to pioglitazone and metformin; 15. Subject is unable to comply with procedures for cognitive and other testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of cognition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Risk of strok; | — |
Countries
China
Contacts
Public ContactXiaodong Pan
Outcome results
None listed