UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038546
Receipt number 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 2022/11/21 22:29:43

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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.
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 or person

Institute

National Cerebral and Cardiovascular Center
Division of Diabetes and Lipid Metabolism

Institute

Department

Personal name



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

Value
https://center6.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