UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039649
Receipt number R000045222
Scientific Title effect of combined aerobic-resistance training on Adropin levels and arterial stiffness in women with type 2 diabetes mellituse
Date of disclosure of the study information 2020/03/01
Last modified on 2023/11/07 17:16:47

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Basic information

Public title

effect of combined aerobic-resistance training in women with type 2 diabetes mellituse.

Acronym

effect of combined aerobic-resistance training in women with type 2 diabetes mellituse

Scientific Title

effect of combined aerobic-resistance training on Adropin levels and arterial stiffness in women with type 2 diabetes mellituse

Scientific Title:Acronym

effect of combined aerobic-resistance training on Adropin levels and arterial stiffness in women with type 2 diabetes mellituse

Region

Asia(except Japan)


Condition

Condition

women diabetic type2.

Classification by specialty

Psychiatry Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1)Effect of combined aerobic-resistance training on Adropin in women with type 2 diabetes mellituse.
2)Effect of combined aerobic-resistance training on Blood sugar levels in women with type 2 diabetes mellituse.
3)Effect of combined aerobic-resistance training on Body fat percentage in women with type 2 diabetes mellituse.
4)Effect of combined aerobic-resistance training on waist-Hip Ratio in women with type 2 diabetes mellituse.
5)Effect of combined aerobic-resistance training on cardio-ankle vascular index (CAVI) in women with type 2 diabetes mellituse.
6)Effect of combined aerobic-resistance training on systole in women diabetic type2 .
7)Effect of combined aerobic-resistance training on diastole in women diabetic type2.
8)Effect of combined aerobic-resistance training on Insulinin women with type 2 diabetes mellituse.
9)Effect of combined aerobic-resistance training on HOMA-IR in women with type 2 diabetes mellituse.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adropin.(pree test and post test)
arterial stiffness.(pree test and post test)
Body fat percentage (pree test and post test)
waist-Hip Ratio. (pree test and post test)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

The experimental group will perform Moderate-intensity combined training (50-70% of maximal heart rate reserve (HRR) and 50-70% of a maximal repetition (1RM)) will be performed three times a week for 12 weeks and 60 minutes per session. Exercise intensity is controlled using the Borg scale and heart rate control at the beginning, middle and end of the exercise with verbal coach feedback, as well as by determining the weights for each intensity of 1RM. Each session consists of 15 minutes of warm-up, 20 minutes of aerobic exercise (walking and running on the treadmill) and resistance training (full body exercises including: upper chest press, shoulder press, lat pull down, leg press, bicep machine curl , tricep extension, steated leg extension, hamstring curl, situps ) are circular, 12 repetitions, 3 rounds, with a 2-3 minute break between rounds and 10 minutes of stretching exercises to cool down.

Interventions/Control_2

The experimental group will perform Moderate-intensity combined training (50-70% of maximal heart rate reserve (HRR) and 50-70% of a maximal repetition (1RM)) will be performed three times a week for 12 weeks and 60 minutes per session. Exercise intensity is controlled using the Borg scale and heart rate control at the beginning, middle and end of the exercise with verbal coach feedback, as well as by determining the weights for each intensity of 1RM. Each session consists of 15 minutes of warm-up, 20 minutes of aerobic exercise (walking and running on the treadmill) and resistance training (full body exercises including: upper chest press, shoulder press, lat pull down, leg press, bicep machine curl , tricep extension, steated leg extension, hamstring curl, situps ) are circular, 12 repetitions, 3 rounds, with a 2-3 minute break between rounds and 10 minutes of stretching exercises to cool down.

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

50 years-old <=

Age-upper limit

75 years-old >=

Gender

Female

Key inclusion criteria

1)BMI>25
2)Menopause
3)No skeletal disease
4)History of diabetes at least 4 years
5)Maximum blood pressure 160 /95 mmHg
6)Age range up to 75 years
7)Fasting blood sugar at least 126
8)Use of blood sugar control medications
9)Lack of metabolic conditions other than type2 diabetes
10)A sedentary lifestyle for at least 6 months.

Key exclusion criteria

1)Insulin therapy
2)Infectious diseases
3)Having skeletal diseases
4)3 sessions of obsenteeism
5)Metabolic conditions Except type2 diabetes



Target sample size

32


Research contact person

Name of lead principal investigator

1st name fatemeh
Middle name
Last name Mohajer Esterabadi

Organization

Shahrood University Of Technology

Division name

Sport Physiology

Zip code

3619995161

Address

Shahrood Haft Tir Square

TEL

00989117002987

Email

fatemeh.mohajer@shahroodut.ac.ir


Public contact

Name of contact person

1st name fatemeh
Middle name
Last name Mohajer Esterabadi

Organization

Shahrood University Of Technology

Division name

Sport Physiology

Zip code

3619995161

Address

Shahrood Haft Tir Square

TEL

00989117002987

Homepage URL


Email

fatemeh.mohajer@shahroodut.ac.ir


Sponsor or person

Institute

Shahrood University Of Technology

Institute

Department

Personal name



Funding Source

Organization

Shahrood University Of Technology

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

Shahrood University Of Technology

Address

Shahrood Haft Tir Square

Tel

00989117002987

Email

fatemeh.mohajer@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

2020 Year 03 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

2020 Year 03 Month 03 Day

Date of IRB

2019 Year 12 Month 07 Day

Anticipated trial start date

2020 Year 03 Month 10 Day

Last follow-up date

2020 Year 07 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 29 Day

Last modified on

2023 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name