UMIN-CTR Clinical Trial

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. 8)Changes in fasting glucose and HbA1c. 9)Changes in blood pressure.

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	109
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	No longer recruiting
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 06 Month 30 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	2022 Year 11 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043878