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

The effect of pioglitazone on cognitive decline in older patients with type 2 diabetes mellitus - Pioglitazone and cognitive function in diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002417

Enrollment

240

Registered

2009-09-08

Start date

2009-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Elderly patients with type 2 diabetes who meet the following criteria: 1. age of 70 to 90 yr, 2. MMSE scores of 24 through 27, 3. HbA1c level of 6.0 % through 8.0 %,

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactAtsushi Araki

Tokyo Metropolitan Geriatric Hospital Endocrinology

aaraki@tmghig.jp03-3964-1141

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026