UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002417 |
|---|---|
| Receipt number | R000002866 |
| Scientific Title | The effect of pioglitazone on cognitive decline in older patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2009/09/08 |
| Last modified on | 2010/02/02 02:02:18 |
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Basic information
Public title
The effect of pioglitazone on cognitive decline in older patients with type 2 diabetes mellitus
Acronym
Pioglitazone and cognitive function in diabetes mellitus
Scientific Title
The effect of pioglitazone on cognitive decline in older patients with type 2 diabetes mellitus
Scientific Title:Acronym
Pioglitazone and cognitive function in diabetes mellitus
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elderly patients in diabetes mellitus are associated with cognitive impairment and dementia. The cognitive impairment makes them difficult to do their self-care activities such as diet, exercise, insulin injections. The cognitive decline in diabetic people has been a major social problem. Insulin resistance, inflammation, and oxidative stress in brain have been proposed to be the mechanism for Alzheimer's disease. Pioglitazone, a thiazolidinedione derivative, may have favorable actions on brain such as improvement of insulin resistance, antiinflammatory, and antioxidant actions. Pioglitazone also inhibits the progression of catotid atherosclerosis and increases cerebral blood flows. Therefore, we will examine whether pioglitazone prevents the cognitive decline in elderly patients with type 2 diabetes mellitus in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
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)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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)
Interventions/Control_2
2. Control group (treated with oral hypoglycemic drugs other than thiazolidinediones, mainly SU drugs)
The two groups are followed up over 5 years.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key 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 %,
Key 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.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Araki |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Endocrinology
Zip code
Address
35-2 Sakae-cho, Itabashiki-ku, Tokyo 173-0015, Japan
TEL
+81-3-3964-1141
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Araki |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Endocrinology
Zip code
Address
35-2 Sakae-cho, Itabashiki-ku, Tokyo 173-0015, Japan
TEL
03-3964-1141
Homepage URL
aaraki@tmghig.jp
Sponsor or person
Institute
Research group (Tokyo Metropolitan Geriatric Hospital and other 12 hospitals)
Institute
Department
Personal name
Funding Source
Organization
Nihon Mediphysics
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2009 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 31 | Day |
Last modified on
| 2010 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002866
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