Pemafibrate Randomized controlled study to Evaluate whether to reduce the risk of new onset of diabetes CompAred with diet therapy in patients with Under pre or early diabetic condiTION complicated with hypertriglyceridemia

Not Applicable

Recruiting

• Conditions: Diabetes

• Registration Number: JPRN-jRCTs031190139
• Lead Sponsor: Osamu Tomonaga

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Fasting triglycerides over 150mg/dL and less than 500 mg / dL, or casual triglycerides over 200 mg / dL and less than 500 mg / dL (values for 12 weeks prior participation can be adopted)
2. Agreed to receive 75g OGTT
3. Aged 20-85 on day of signing informed consent
4. Patients who have received sufficient explanation for participation in this study, and who have fully understood the study plan and consented to the document by their own will

Exclusion Criteria

1. Currently receiving or are planning to receive diabetes agents
2. Treated with fibrate agents within 12 weeks prior to the study
3. Patients who have changed prescriptions for antihypertensive and dyslipidemia agents (including rotriga and epadale) within 12 weeks prior to the study
4. Patients who fall under a contraindication listed in the pemafibrate package insert
5. Patients with a history of malignant tumor or patients who are likely to relapse after remission
6. Patients who are determined to be inappropriate for this study by the principal investigator or research investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in blood glucose level AUC0-2h by 75g OGTT from baseline to 12 weeks (parallel group)

Secondary Outcome Measures

Name	Time	Method
- Changes of various parameters from baseline to the 12th week by 75g OGTT (before / after / parallel group)<br>- Changes of various parameters from baseline to the (4)12th week (before / after / parallel group)<br>- Percentage of transition from borderline to diabetic or normal, diabetic to borderline or normal<br>- Occurrence of adverse events and diseases