Plain English Summary
Background and study aims
It is well known that the risk of cognitive disorder increases in diabetes patients, but there is no consensus regarding when patients should have a cognitive test or who should have the test. Because the cognitive test takes time, it is difficult to have a cognitive test for all diabetes patients. Searching the clinical parameters distinguished in diabetes patient saves time and effort. The aim of this study is to find out whether there is a high-risk group that should be considered for cognitive function testing in diabetes treatment.
Who can participate?
Patients with diabetes who were admitted to the Department of Diabetes and Metabolic Diseases at The University of Tokyo Hospital between 17/07/2016 and 31/03/2017.
What does the study involve?
Patient information is collected on the day of hospitalization and fasting blood samples are collected soon after obtaining informed consent.
What are the possible benefits and risks of participating?
The benefit is if the MMSE score has declined, the patient can have a medical examination of cognitive function, and can have treatment as quickly as possible. The risk is bleeding from blood collection.
Where is the study run from?
The University of Tokyo Hospital
When is the study starting and how long is it expected to run for?
The study was approved on 06/06/2016 and the recruitment was finished on 31/03/2017.
Who is funding the study?
University of Tokyo (Japan)
Who is the main contact?
Dr Yuka Kobayashi
kobayashiyu-int@h.u-tokyo.ac.jp
Trial website
Contact information
Type
Public
Primary contact
Dr Yuka Kobayashi
ORCID ID
Contact details
7-3-1 Hongo
Bunkyo-ku
Tokyo
1138655
Japan
+81 (0)3 5800 8815
kobayashiyu-int@h.u-tokyo.ac.jp
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
11171
Study information
Scientific title
Which parameter is specific between normal cognitive function and declined cognitive function in diabetes patients?
Acronym
N/A
Study hypothesis
It is well known that the risk of cognitive disorder increases in diabetes patients. But, there is no consensus when patients should have a cognitive test or who should have the test. Because a cognitive test takes time, it is difficult to have a cognitive test for all diabetes patients. Searching the clinical parameters distinguished in diabetes patients saves time and effort.
Ethics approval
Approved 06/06/2016, Ethics Committee of the University of Tokyo (Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Faculty of Medicine Bldg.2 4F 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan; Tel: +81 (0)3 5841 0818; Email: ethics@m.u-tokyo.ac.jp), No. 11171
Study design
Single-center observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
No participant information sheet available
Condition
Diabetes mellitus
Intervention
The researchers investigated the following parameters: sex, age, disease duration, body mass index (BMI), smoking, alcohol consumption, family history of diabetes mellitus, coronary artery disease, stroke, neuropathy, retinopathy, nephropathy, systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure, diabetic treatment, use of antihypertensive drugs, use of lipid-lowering drugs, HbA1c, glycoalbumin (GA), GA/HbA1c ratio, homeostasis model assessment-insulin resistance (HOMA-IR), fasting C-peptide immunoreactivity (CPR), 2-h-after-meal CPR, C-peptide Index (CPI), fasting plasma glucose (FPG), serum albumin (Alb), uric acid (UA), triglycerides (TG), calculated LDL cholesterol (c-LDL), blood urea nitrogen (BUN), creatinine (Cre), estimated glomerular filtration rate (eGFR), HNA% and Mini Mental State Examination (MMSE) score. Doctors and nurses answered a questionnaire which percent they think the patient has cognitive dysfunction before knowing the MMSE score. Neuropathy was diagnosed when the patient has at least one of the following findings: (1) coefficient of variation of R-R intervals (CVR-R) under 2%, (2) reduction in Achilles tendon reflex, (3) decreased lower limb vibration sensing, (4) and the presence of obvious sensory impairment. Retinopathy was diagnosed and classified into normal (-), simple diabetic retinopathy (SDR), pre-proliferative diabetic retinopathy (PPDR), or proliferative diabetic retinopathy (PDR), according to the Davis classification. Nephropathy stage was determined by urinary albumin excretion and eGFR, according to the Classification of Diabetic Nephropathy 2014 proposed by the Joint Committee on Diabetic Nephropathy in Japan. Patient background information was collected on the day of hospitalization and fasting blood samples were collected soon after obtaining informed consent.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Cognitive dysfunction is measured using the Mini Mental State Examination (MMSE) score after getting consent.
Secondary outcome measures
Oxidative stress is measured using human non-mercaptalbumin (HNA%) from a morning blood test taken on the first day after getting consent.
Overall trial start date
01/01/2012
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inpatients diagnosed with diabetes mellitus, who were admitted to the Department of Diabetes and Metabolic Diseases at The University of Tokyo Hospital between 17/07/2016 and 31/03/2017
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Total final enrolment
200
Participant exclusion criteria
1. Pregnant
2. Lactating
3. Acute organ failure (e.g., pneumonia, acute myocardial infarction, acute cerebral infarction, diabetic ketoacidosis, and hyperosmolar hyperglycemic state)
4. Congenital cognitive disorders
Recruitment start date
17/07/2016
Recruitment end date
31/03/2017
Locations
Countries of recruitment
Japan
Trial participating centre
Tokyo University Hospital
7-3-1 Hongo, Bunkyo-ku
Tokyo
1138655
Japan
Sponsor information
Organisation
University of Tokyo
Sponsor details
7-3-1 Hongo
Bunkyo-ku
Tokyo 113-8655
Japan
Tokyo
113-8655
Japan
+81 (0)3 5800 8815
kobayashiyu-int@h.u-tokyo.ac.jp
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Tokyo
Alternative name(s)
The University of Tokyo, 東京大学憲, 도쿄대학, 东京大学设, Utokyo
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Japan
Funder name
Nakatani Foundation for Advancement of Measuring Technologies in Biomedical Engineering
Alternative name(s)
Nakatani Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Japan
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Yuka Kobayashi (yukaodawara@aol.com or kobayashiyu-int@h.u-tokyo.ac.jp).
Intention to publish date
30/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list