UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059908 |
|---|---|
| Receipt number | R000068518 |
| Scientific Title | The effect of endurance training on BMP4 as a mediator of Cardio-Ankle Vascular Index in women with type 2 diabetes with peripheral neuropathy: A randomized controlled trial |
| Date of disclosure of the study information | 2025/11/28 |
| Last modified on | 2025/11/28 02:50:50 |
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Basic information
Public title
The effect of endurance training on BMP4 as a mediator of Cardio-Ankle Vascular Index in women with type 2 diabetes with peripheral neuropathy: A randomized controlled trial
Acronym
effect of endurance training on BMP4 and arterial stiffness in type 2 diabetes
Scientific Title
The effect of endurance training on BMP4 as a mediator of Cardio-Ankle Vascular Index in women with type 2 diabetes with peripheral neuropathy: A randomized controlled trial
Scientific Title:Acronym
effect of endurance training on BMP4 and arterial stiffness in type 2 diabetes
Region
| Asia(except Japan) |
Condition
Condition
women diabetic type2
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Effect of endurance training on BMP-4 in type-2 diabetic Women with peripheral neuropathy.
2)Effect of endurance training on CAVI in type-2 diabetic Women with peripheral neuropathy.
3)Effect of endurance training on Blood sugar levels in type-2 diabetic Women with peripheral neuropathy.
4)Effect of endurance training on Insulin in type-2 diabetic Women with peripheral neuropathy.
5)Effect of endurance training on HOMA-IR in type-2 diabetic Women with peripheral neuropathy.
6)Effect of endurance training on Body fat percentage in type-2 diabetic Women with peripheral neuropathy.
7)Effect of endurance training on Systolic BP in type-2 diabetic Women with peripheral neuropathy.
8)Effect of endurance training on Diastolic BP in type-2 diabetic Women with peripheral neuropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BMP-4.(pree test and post test)
CAVI.(pree test and post test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention group will undergo 12 weeks of supervised aerobic endurance training (3 sessions/week, 60-75 min/session) on treadmills. Session structure will consist of: 1) warm-up (10 min brisk walking + dynamic stretching). 2) main aerobic phase (weeks 1-2: 20-25 min; weeks 3-6: 30-35 min; weeks 7-10: 35-40 min; weeks 11-12: 45 min). 3) intensity of 50-70% heart rate reserve (Karvonen formula) progressively increasing from 50-55% (weeks 1-4) to 60-65% (weeks 5-8) and then to 70% (weeks 9-12). 4) cool-down (5-10 min light walking + stretching).
Interventions/Control_2
control group(for a three-month research program): no treatment. Continue their former lifestyle.
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
| 40 | years-old | < |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Inclusion criteria will be:
postmenopausal status (>=12 months amenorrhea),
T2DM diagnosed according to ADA criteria with stable HbA1c (7.0-9.0% for >=12 months),
fasting plasma glucose >126 mg/dL,
MNSI score >7,
BMI 25-39.9 kg/m^2,
sedentary lifestyle (<1 structured exercise session/week).
Key exclusion criteria
Exclusion criteria will be:
insulin therapy,
uncontrolled hypertension (>=180/110 mmHg),
cardiovascular event or revascularization in the past 12 months,
active diabetic foot ulcer or Charcot arthropathy,
severe neuropathy impairing safe exercise (MNSI >=10 or inability to walk 1.6 km),
renal impairment (eGFR <45 mL/min/1.73 m^2),
smoking,
malignancy,
thyroid disease or inflammatory disorders,
and participation in a regular exercise or weight-loss program.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | adel |
| Middle name | |
| Last name | donyaei |
Organization
Shahrood University Of Technology
Division name
Physical Education and Sport Sciences
Zip code
3619995161
Address
Shahrood, Haft Tir Square, Shahrood University of Technology
TEL
098-2332395900
adelldonyai@yahoo.com
Public contact
Name of contact person
| 1st name | adel |
| Middle name | |
| Last name | donyaei |
Organization
Shahrood University Of Technology
Division name
Physical Education and Sport Sciences
Zip code
3619995161
Address
Shahrood, Haft Tir Square, Shahrood University of Technology
TEL
098-2332395900
Homepage URL
adelldonyai@yahoo.com
Sponsor or person
Institute
Shahrood University Of Technology
Institute
Department
Personal name
Funding Source
Organization
NO
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Shahrood University of Technology
Address
Shahrood, Haft Tir Square, Shahrood University of Technology, Faculty of Physical Education and Sport Sciences
Tel
098-2332395900
Ethics.C@shahroodut.ac.ir
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
| 2025 | Year | 11 | Month | 28 | 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
38
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068518
