NCT02754739

Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

An increased risk of incident diabetes with statin therapy have been reported in several studies. However, it is not recommended to limit the use of statin for this reason since the absolute risk increase was small, and the cardiovascular event rate reduction with statins overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin may have different effect on the development of incident diabetes. In the West of Scotland Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by 30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the improvement in insulin sensitivity, has been reported. In this clinical trial, the investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin secretion, glycemic control, and adiponectin level in participants with prediabetes or early diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.

Conditions

• Diabetes Mellitus
• Prediabetic State

Interventions

Type	Name	Description
DRUG	Pravastatin	Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist
DRUG	Placebo (for Pravastatin)	Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist
BEHAVIORAL	Nutritional education only	Only nutritional education by a nutritionist

Timeline

• Start date: 2014-04-15
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2016-04-28
• Last updated: 2018-09-13

Locations

1 site across 1 country: South Korea