Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/08/2019
Date assigned
07/09/2019
Last edited
06/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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)

Utokyo

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

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

foundation

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

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/09/2019: Trial's existence confirmed by ethics committee.