Effects of fenofibrate or eiocosapentaenoic acid(EPA) on glucose metabolism, fat distribution, adipocytokines and inflammatory cytokines in type 2 Diabetes.

UMIN ID: UMIN000000969

Registered date:07/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 Diabetes
• Date of first enrollment: 2008/01/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

fenofibrate (100-200mg/day)
eicosapentaenoic acid(EPA) (1800mg/day)

Outcome(s)

• Primary Outcome: 1. Evaluation of the effects on glucose metabolism and insulin sensitivity calculated with oral glucose tolerance test before and after 12 weeks treatment. 2. Measurement of the amount visceral fat, intramyocellular lipid content(IMCL) and hepatic lipid content(HLC) before and after 12 weeks treatment.
• Secondary Outcome: 3. Measurement of HbA1c, total-cholesterol, LDL-cholesterol, triglyceride, FFA, oxidized LDL, Lipoprotein(a), remnant-like particle lipoorotein(RLP), adipocytokines, inflammatory cytokines, oxidative stress marker before and after 12 weeks treatment. 4. Measurement of body weight and waist before and after 12 weeks treatment.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Severe hypercholesterolemia(LDL>140mg/dl) 2. Severe deficiency of insulin secretion 3. Severe renal dysfunction (serum creatinin>2.0mg/dl) 4. Severe liver dysfunction (AST, ALT>50IU/ml) 5. Severe herat failure 6. History of hypersensitivity to pioglitazone or metformin. 7. During the pregnancy and nursing 8. Inadequately BS contrilled (FBG>150mg/dl) 9. Inadequate to entry this study

Related Information

• Primary Sponsor: Kobe University Hospital
• Secondary Sponsor: Kobe University Graduate School of Medicine Department of radiology
• Source(s) of Monetary Support: None