UMIN ID: UMIN000000725
Registered date:30/05/2007
Glycemic control and Oxidative stress with Glimepiride or Nateglinide alone in type 2 OHA naive diabetic patients.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | type 2 diabetes |
| Date of first enrollment | 2007/01/01 |
| Target sample size | 140 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Glimepiride group: Starting dose will be 0.5mg/day or 1mg/day at before breakfast or after breakfast depending on the conditions of patients. Maximum dosage is 6mg/day, and treatment period is for 6 month Treatment period is for 6 month. Nateglinide group: Starting dose should be determined depending on the conditions of patients. Timing of dosing should be before each (maximum 360mg/day). |
Outcome(s)
| Primary Outcome | Change of HbA1c |
|---|---|
| Secondary Outcome | 1)FPG, Fasting IRI, Achievement ratio of HbA1c below 6.5%. 2)TC,TG,HDL-C,LDL-C,BW,BMI,HOMA-IR 3)Urinal 8-OHdG, hs-CRP, Adiponectin, High Molecular Weight Adiponectin, High Sensitive TNF-a, TGF-b |
Key inclusion & exclusion criteria
| Age minimum | 30years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Exclusion Criteria: 1) Patients except type 2 diabetic patients. 2) Patients taking Probucol, vitamin E and/or vitamin C. 3) Alcoholic,or heavy drinker. 4) Patients operated malignant and gastro extraction. 5) Patients with serious complications of DM. Nephropathy:*. Retinopathy:** 6) Drug anaphylaxis patient. 7) Pregnant or patients who plan to carry, or currently breast-feeding woman. 8) Patients who were judged inappropriate to participate in this study by the doctor of study director or cooperative *Proteinuria >= 1g/day ** Stage of preproliferative and proliferative retinopaty by Davis classification |
Related Information
| Primary Sponsor | Tokyo Medical University The 3rd Department of Internal Medicine |
|---|---|
| Secondary Sponsor | Ryokuseikai Hospital Akishima Hospital Ryokuhuso Hospital Niiza Shiki Chuo general Hospital Nishi Tokyo Chuo general Hospital Toda Chuo general Hospital Ebara Hospital |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takashi Miwa |
| Address | 160-0023 6-7-1, Shinjuku ku, Nishi shinjuku, Tokyo Japan |
| Telephone | 03-3342-6111 |
| Affiliation | Tokyo Medical University The 3rd Department of Internal Medicine |
| scientific contact | |
| Name | Masato Odawara |
| Address | 160-0023 6-7-1, Shinjuku-ku, Nishi-shinjuku, Tokyo Japan |
| Telephone | 03-3342-6111 |
| Affiliation | Tokyo Medical University The 3rd Department of Internal Medicine |