UMIN ID: UMIN000012197
Registered date:05/11/2013
The effect of regular exercise and regular exercise with teneligliptin on plasma GLP-1 concetration in the elderly patients with type 2 diabetes
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | type 2 diabetes |
| Date of first enrollment | 2013/11/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | no physical exercise habit physical exercise habit no physical exercise habit with treatment of 20mg/day teneligliptin physical exercise habit with treatment of 20mg/day teneligliptin |
Outcome(s)
| Primary Outcome | 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 |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | 70years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Geriatric Medicine, Osaka University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Geriatric Medicine, Osaka University Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ken Sugimoto |
| Address | 2-2, Yamada-oka, Suita, Osaka Japan |
| Telephone | 06-6879-3852 |
| sugimoto@geriat.med.osaka-u.ac.jp | |
| Affiliation | Osaka University Graduate School of Medicine Geriatri Medicine |
| scientific contact | |
| Name | Ken Sugimoto |
| Address | 2-2, Yamada-oka, Suita, Osaka Japan |
| Telephone | 06-6879-3852 |
| sugimoto@geriat.med.osaka-u.ac.jp | |
| Affiliation | Osaka University Graduate School of Medicine Geriatric Medicine |