Multicenter clinical trial of pioitazone in type 2 diabetes: impact on expression of soluble receptor for advanced glycation end-products (PioRAGE)

UMIN ID: UMIN000002055

Registered date:09/06/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2009/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

pioglitazone 15-30 mg/day
glimepiride 1-4 mg/day

Outcome(s)

• Primary Outcome: serum soluble form of receptor for advanced glycation end-products(sRAGE), serum endogenous secretory RAGE(esRAGE)
• Secondary Outcome: 1)surface RAGE expression on isolated peripheral blood mononuclear cells (PBMCs) 2)serum adiponectin, serum fetuin A, serum TNF-related apoptosis-inducing ligand(TRAIL), serum osteoprotegerin(OPG), serum high sensitivity C-reactive protein(hs-CRP) 3)gene expression of PBMCs(RAGE, ADAM10, ADAM17) 4)serum carboxymethyllysine(CML)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)subjects currently on pioglitazone therapy 2)subjects under treatment with insulin 3)subjects under treatment with glimepiride 3-6 mg/day or gliclazide 80-160 mg/day or glibenclamide 5-10 mg/day 4)subjects with congestive heart failure 5)subjects with liver cirrhosis 6)subjects with renal dysfunction (serum creatinine level is 2.0 mg/dl or more) 7)subjects with malignant diseases or hard to be followed 8)subjects who were judged to be inappropriate for inclusion

Related Information

• Primary Sponsor: PioRAGE research group
• Source(s) of Monetary Support: Osaka City University Graduate School of Medicine