UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of regular exercise and regular exercise with teneligliptin on plasma GLP-1 concetration in the elderly patients with type 2 diabetes
Title of the study (Brief title)	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	Ken Sugimoto
Organization	Osaka University Graduate School of Medicine
Division name	Geriatric Medicine
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	Ken Sugimoto
Organization	Osaka University Graduate School of Medicine
Division name	Geriatri Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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