Investigation of a high-risk group that should be considered for cognitive function testing in diabetes treatment
| ISRCTN | ISRCTN11818569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11818569 |
| Secondary identifying numbers | 11171 |
- Submission date
- 29/08/2019
- Registration date
- 07/09/2019
- Last edited
- 10/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Public
7-3-1 Hongo
Bunkyo-ku
Tokyo
1138655
Japan
| Phone | +81 (0)3 5800 8815 |
|---|---|
| kobayashiyu-int@h.u-tokyo.ac.jp |
Study information
| Study design | Single-center observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Which parameter is specific between normal cognitive function and declined cognitive function in diabetes patients? |
| Study acronym | N/A |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2012 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/07/2016 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- Japan
Study participating centre
Tokyo
1138655
Japan
Sponsor information
University/education
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
Tokyo
113-8655
Japan
| Phone | +81 (0)3 5800 8815 |
|---|---|
| kobayashiyu-int@h.u-tokyo.ac.jp | |
"ROR" |
https://ror.org/057zh3y96 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- The University of Tokyo, 東京大学憲, 도쿄대학, 东京大学设, Utokyo
- Location
- Japan
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Nakatani Foundation
- Location
- Japan
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | 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). |
Editorial Notes
10/12/2019: The following changes have been made:
1. The intention to publish date has been changed from 31/12/2019 to 30/06/2020.
2. The total final enrolment number has been added.
02/09/2019: Trial's existence confirmed by ethics committee.
