The effect of pioglitazone on cognitive decline in older patients with type 2 diabetes mellitus

UMIN ID: UMIN000002417

Registered date:08/09/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: diabetes mellitus
• Date of first enrollment: 2009/09/01
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Elderly patients with diabetes mellitus are randomly allocated to one arm of the two groups as matched with respect to age, sex, HbA1c, treatment of diabetes. 1. Pioglitazone treatment group (7.5 mg to 45 mg daily)
2. Control group (treated with oral hypoglycemic drugs other than thiazolidinediones, mainly SU drugs) The two groups are followed up over 5 years.

Outcome(s)

• Primary Outcome: Cognitive decline (more than 20% decline of cognitive function test: MMSE, ADAS, digit symbol test, logical memory, trail-making test, or 10 words delayed recall or at least one stage worsing of CDR) or development of dementia (probable Alzheimer's disease based on the ADRDA, or probable vascular dementia defined by the NINCDS-AIREN)
• Secondary Outcome: 1.cognitive function (Z scores of MMSE, ADAS, digit symbol test, logical memory, trail-making test, and 10 words delayed recall), 2.cerebral blood flows by SPECT, 3.brain atrophy on MRI, 4.vascular comlications: non-fatal stroke, non-fatal IHD, all-cause death, cardiovascular death, progression of nephropathy, 5.carotid IMT and carotid artery stenosis, 6.ADL, depression, and fall, 7.incidence of hypoglycemia, 8.congestive heart failure, 9.HbA1c, serum glucose, lipids, insulin, adiponectin, waist circumference, RBC, and liver function

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 1. patients with type 1 diabetes mellitus including slowly progressive IDDM, 2. anti-GAD antibody positive patients, 3. insulin-treated patients, 4. psychiatric patients including dementia and depression and neurodegenerative disease (Parkinson disease). 5. patients with symptomatic stroke, 6. patients with poorly controlled blood pressure (systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg), 7. patients with unstable blood pressures or orthostatic hypotension, 8. patinets with alcohol intoxication, 9. patients who had a history of head injury. 10. patients with hypoxia, 11. patinets with chonic renal failure (serum CRE >2.0 mg/dl for men, serum CRE> 1.5 mg/dl), 12. patients with severe liver damage, 13. patients with a history of acure myocardial infarction, 14. patients with history of coronary bypass or coronary angioplasty, 15. patients with histoty of heart failre or BNP>150 pg/ml, patients with a history of pioglitazone or donepezil, 16. patients whom doctors judge to be not suitable for the trial.

Related Information

• Primary Sponsor: Research group (Tokyo Metropolitan Geriatric Hospital and other 12 hospitals)
• Source(s) of Monetary Support: Nihon Mediphysics