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Effects of beraprost sodium sustained-release tablet on improvement of insulin resistance in patients with type 2 diabetes with obesity in a Double-Blinded, Randomized, Placebo-Controlled, Crossover Trial.

Not Applicable
Recruiting
Conditions
Patients with type 2 diabetes and obesity
Registration Number
JPRN-UMIN000008469
Lead Sponsor
Graduate School of Medicine, University of Tokyo Department of Metabolic Diseases
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Patients with bleeding tendency Patients with Type 1 diabetes or secondary diabetes Patients with severe renal dysfunction Patients with liver dysfunction Patients with a past history if drug hypersensitivity Pregnant women or women with breast-feeding Patients who took prostaglandin derivatives within 3 months Patients whose prescription drugs were changed within 3 months All Patients who is unsuitable for this trial at a physician's discretion

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the effects of beraprost sodium sustained-release tablets and placebo on the insulin resistance by glucose infusion rate on euglycemic hyperinsulinemic clamp
Secondary Outcome Measures
NameTimeMethod
1. HOMA-IR (Homeostasis model assessment-Insulin Resistance) To evaluate the effects on the insulin resistance. 2. Fasting blood glucose, Glycoalbumin, HbA1c To evaluate the effects on the glycemic control. 3.ADMA, %FMD To evaluate the effects on the vascular endotherial function.
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