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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002417
Receipt No. 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

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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
Email

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
Email aaraki@tmghig.jp

Sponsor
Institute Research group (Tokyo Metropolitan Geriatric Hospital and other 12 hospitals)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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