UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012197 |
|---|---|
| Receipt number | 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 17:51:05 |
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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
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
sugimoto@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Geriatric Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014257
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