UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057177 |
|---|---|
| Receipt number | R000065360 |
| Scientific Title | Evaluation and investigation of orthostatic hypotension in Type 2 diabetes in terms of lower limb muscle mass: Comparative study of blood pressure variability associated with positional changes |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/02/28 17:06:16 |
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Basic information
Public title
Relationship Between Lower Body Muscle Mass and Dizziness in Diabetes:A Study on Blood Pressure Changes with Postural Shifts
Acronym
Relationship Between Lower Body Muscle Mass and Dizziness in Diabetes:A Study on Blood Pressure Changes with Postural Shifts
Scientific Title
Evaluation and investigation of orthostatic hypotension in Type 2 diabetes in terms of lower limb muscle mass: Comparative study of blood pressure variability associated with positional changes
Scientific Title:Acronym
Evaluation and investigation of orthostatic hypotension in Type 2 diabetes in terms of lower limb muscle mass: Comparative study of blood pressure variability associated with positional changes
Region
| Japan |
Condition
Condition
Type 2 diabetes and healthy subjects
Classification by specialty
| Medicine in general | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of lower extremity muscle mass on the frequency and severity of type 2 diabetic orthostatic hypotension. We will follow those who are hospitalized for diabetes education for 3 months from that point to find out how it changes.
Basic objectives2
Others
Basic objectives -Others
To clarify how blood pressure variability during orthostasis in patients with type 2 diabetes mellitus differs from that in healthy subjects.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of changes in blood pressure and lower limb muscle mass during standing at admission, at discharge, and around 3 months after discharge
Comparison of blood pressure changes during standing and other changes in healthy subjects and type 2 diabetes mellitus
Key secondary outcomes
Change in HbA1c at admission and around 3 months after discharge
Comparison of diabetic lifestyle questionnaires at admission and around 3 months after discharge
Comparison of subjective symptoms of orthostatic hypotension at admission, at discharge, and around 3 months after discharge
Cardiac output, heart rate, R-R interval
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Common:
(1) Those who are independent in their daily lives.
(2) Those who are able to quit smoking and drinking on the day of the standing test.
(3) Those who are hungry or have eaten for at least 2 hours prior to the test.
Subjects:
Type 2 diabetics: Patients who are hospitalized for glycemic control, scheduled retinopathy surgery, or diabetes education.
Healthy subjects: (1) Those who do not have specific chronic diseases (diabetes, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, Parkinson's disease, etc.) and have no difficulty in daily living (2) Those who have had or will have a hemoglobin A1c (HbA1c: 4.0~6.4%) blood test within 2 months before or after the day they wish to participate in the study or are scheduled to take the test.
Key exclusion criteria
(i) Patients with type 2 diabetes mellitus
2) Patients who use the following drugs (drugs that affect the autonomic nervous system, tranquilizers, psychostimulants, levodopa and other drugs for the treatment of Parkinson's disease, vasodilators, etc.)
Persons who have exercised in a way that causes heavy exhalation on the day of the examination.
Subjects who wear a pacemaker.
Persons who are deemed inappropriate as research subjects by the principal investigator.
(2) Normal subjects:
Persons using the following drugs (drugs that affect the autonomic nervous system, tranquilizers, psychostimulants, levodopa and other drugs for the treatment of Parkinson's disease, vasodilators, hypertension, etc.)
Persons with the following chronic diseases (heart disease, chronic obstructive pulmonary disease, chronic kidney disease, Parkinson's disease, etc.)
Persons who have exercised on the day of the examination in a way that causes heavy exhalation.
Persons who wear a pacemaker.
Persons who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Takeno |
Organization
Nagoya University
Division name
Department of Nursing, Graduate School of Medicine
Zip code
461-8673
Address
1-1-20, Daiko Minami, Higashi-ku, Nagoya, Aichi, Japan
TEL
052-719-1518
zhang.qingbo.r9@s.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | QINGBO |
| Middle name | |
| Last name | ZHANG |
Organization
Nagoya University
Division name
Department of Nursing, Graduate School of Medicine
Zip code
461-8673
Address
1-1-20, Daiko Minami, Higashi-ku, Nagoya, Aichi, Japan
TEL
052-719-1518
Homepage URL
zhang.qingbo.r9@s.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-741-2111
ethics@med.nagoya-u-ac-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
名古屋大学医学部附属病院（愛知県）、重工大須病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was conducted as a case-control study. All patients who visited or underwent physical examinations at our facilities (Nagoya University Hospital and Osu Hospital) between October 2023 and January 2025 and met the selection criteria were included in the study.
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065360
