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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038546
Receipt No. R000043878
Scientific Title Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus
Date of disclosure of the study information 2019/11/11
Last modified on 2019/11/11

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Basic information
Public title Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus
Acronym Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus
Scientific Title Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus
Scientific Title:Acronym Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus
Region
Japan

Condition
Condition type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the relationships between glucose fluctuaion and cognitive functions in a prospective longitudinal study.
Basic objectives2 Others
Basic objectives -Others To elucidate the mechanism that patients with diabetes are at high risk of impaired cognitive function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationships between the indexes obtained from CGM (Libre Pro) data and the change of score of Montreal Cognitive Assessment and Alzheimer's Disease Assessment Scale.
Key secondary outcomes 1)Development of CV event; cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization due to unstable angina pectoris or heart failure, or myocardial revascularization.
2)Development of renal event; progression of diabetic kidney disease stage, initiation of renal replacement therapy or doubling of the serum creatinine level from baseline.
3)Changes of Brain Observer Micro Bleed Scale (BOMBS), Fazekas scale, Cerebral small vessel disease (SVD) score and % stenosis of intracranial artery assessed by WASID method. These parameters are obtained by MRI and MRA of the head.
4)Changes of GDS and Apathy scale.
5)Changes of Morisky score.
6)Changes of intima-media thickness (IMT) in the distal wall of both common carotid arteries at 1 centimeter from bifurcation assessed by carotid artery echography.
7)Changes of hs-CRP and IL-6.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)patients with type 2 diabetes mellitus who are treated at National Cerebral and Cardiovascular Center.
2)patients who receive sulphonylurea, glinide and/or insulin, or patients with HbA1c7.0% or more who receive other oral hypoglycemic agents and/or glucagon-like peptide 1 receptor agonist.
3)the Montreal Cognitive Assessment (MoCA) score is between 17 and 25.
Key exclusion criteria 1)undergoing renal replacement therapy.
2)receiving therapy for malignancy
3)taking antidementia drugs or underlying comorbidities affecting cognitive function (depression, thyroid dysfunction or deficiency of vitamin B1, B12 or folate).
4)carotid-artery stenosis greater than 80% luminal area.
5)judged as inappropriate by the clinical investigators.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hosoda
Middle name
Last name Kiminori
Organization National Cerebral and Cardiovascular Center
Division name Division of Diabetes and Lipid Metabolism
Zip code 564-8565
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
TEL 0661701070
Email kiminorihosoda@ncvc.go.jp

Public contact
Name of contact person
1st name Matsubara
Middle name
Last name Masaki
Organization National Cerebral and Cardiovascular Center
Division name Division of Diabetes and Lipid Metabolism
Zip code 564-8565
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
TEL 0661701070
Homepage URL
Email matsubara.m@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Division of Diabetes and Lipid Metabolism
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cerebral and Cardiovascular Center
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
Tel 0661701070
Email rec-office-ac@ncvc.go.jp

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
2019 Year 11 Month 11 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 02 Day
Date of IRB
2018 Year 10 Month 30 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective, single center, observational study to elucidate the relationships between glucose fluctuation and cognitive function. The observation period is 2 years and in this study glucose fluctuation assessed using continuous glucose monitoring (Libre Pro) and cognitive test (Montreal Cognitive Assessment and Alzheimer's Disease Assessment Scale) are evaluated at baseline, 1-year visit and 2-year visit in elderly patients (65-85 years) with type 2 diabetes mellitus (DM) showing mild cognitive impairment (MCI). The target number of enrolled patients was set at 100 subjects who regularly attended the outpatient diabetes clinic at National Cerebral and Cardiovascular Center in Japan.

Management information
Registered date
2019 Year 11 Month 11 Day
Last modified on
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043878

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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