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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012197
Receipt No. R000014257
Scientific Title The effect of regular exercise and regular exercise with teneligliptin on plasma GLP-1 concetration in the elderly patients with type 2 diabetes
Date of disclosure of the study information 2013/11/05
Last modified on 2017/09/08

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Basic information
Public title The effect of regular exercise and regular exercise with teneligliptin on plasma GLP-1 concetration in the elderly patients with type 2 diabetes
Acronym The effect of regular exercise and regular exercise with teneligliptin on plasma GLP-1 concetration in the elderly patients with type 2 diabetes
Scientific Title The effect of regular exercise and regular exercise with teneligliptin on plasma GLP-1 concetration in the elderly patients with type 2 diabetes
Scientific Title:Acronym The effect of regular exercise and regular exercise with teneligliptin on plasma GLP-1 concetration in the elderly patients with type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of regular exercise and regular exercise with DPP-4 inhibitor (teneligliptin) on plasma IL-6 or GLP-1 concentration in the elderly patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) The changes in plasma IL-6 or GLP-1 concentration after training in the subjects with or without regular exercise
2) The changes in plasma IL-6 or GLP-1 concentration at rest in the subjects treated with or without teneligliptin, and the enchancing effect on the changes in plasma IL-6 or GLP-1 concentration by the treatment of teneligliptin
Key secondary outcomes The change in
1) fasting blood glucose, HbA1c
2) BMI
3) serum creatinine level
4) plasma IL-6 concentration
5) plasma active GLP-1 concentration
6) intima media thickness (IMT) by carotid ultrasonography

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 no physical exercise habit
Interventions/Control_2 physical exercise habit
Interventions/Control_3 no physical exercise habit with treatment of 20mg/day teneligliptin
Interventions/Control_4 physical exercise habit with treatment of 20mg/day teneligliptin
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients with type 2 diabetes, 70 years of age and older
2) The subjects without previous cardiovascular or respiratory diseases and abnormality of the electrocardiogram
3) The subjects with poorly-controlled diabetes (HbA1c 6.0-8.0%) by:
1. sulfonylureas with diet and exercise
2. thiazolidinediones with diet and exercise
3. alpha-glucosidase inhibitors with diet and exercise
Key exclusion criteria 1) the patients wiht type 1 diabetes
2) the subjects whose HbA1cs are below 6.0% or over 8.0%
3) the subjects who cannot reduce the dosage of sulfonylureas (using more than 2mg/day of glimepiride, 1.25mg/day of glibenclamide, 40mg of gliclazide
4) the subjects with poorly-controlled hypertension (systolic blood pressure >160mmHg)
5) the subjects with a diagonosis of effort angina, chronic heart failure(class II of NHYA classification and more) and tachyarrhythmia
6) the subjects with a diagnosis of chronic respiratory failure(class II of Hugh-Jones classification and more)
7) the subjects who cannot pedal a bike for about 30min
8) the subjects with shorter time of one leg standing (<15sec)
9) the subjects in active treatment for hypothyroidism
10) the subjects with severe liver dysfunction: more than 100IU/L of AST and ALT level
11) the subjects already enrolled in other clinical trial
12) the subjects found offensive by attending physicians for this research
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Sugimoto
Organization Osaka University Graduate School of Medicine
Division name Geriatric Medicine
Zip code
Address 2-2, Yamada-oka, Suita, Osaka
TEL 06-6879-3852
Email sugimoto@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sugimoto
Organization Osaka University Graduate School of Medicine
Division name Geriatri Medicine
Zip code
Address 2-2, Yamada-oka, Suita, Osaka
TEL 06-6879-3852
Homepage URL http://www.med.osaka-u.ac.jp/pub/geriat/www/index_g.html
Email sugimoto@geriat.med.osaka-u.ac.jp

Sponsor
Institute Geriatric Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Geriatric Medicine, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 11 Month 05 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 Terminated
Date of protocol fixation
2013 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 01 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014257

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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