NCT07378293

Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers

Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shaheed Benazir Bhutto University Sheringal Dir Upper · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase I randomized clinical trial aims to investigate the short-term effects of three commonly prescribed statins (atorvastatin, rosuvastatin, and simvastatin) at different dose levels on blood glucose homeostasis in healthy volunteers. The study will assess changes in fasting blood glucose, insulin, and C-peptide levels following two days of statin administration under controlled conditions. The research seeks to provide comparative data on the potential diabetogenic effects of these medications.

Detailed description

This study addresses emerging evidence suggesting statin therapy may modestly increase diabetes risk in a dose-dependent manner. The trial will enroll healthy volunteers who will be randomized to receive one of three statins at low, moderate, or high doses for two days. Blood glucose will be measured using standardized glucometers, while insulin and C-peptide levels will be determined using ELISA assays. The study aims to clarify whether different statins have varying effects on glucose metabolism during short-term exposure and to establish dose-response relationships.

Conditions

• Diabete Mellitus
• Lipid Profile

Interventions

Type	Name	Description
DRUG	Simvastatin (10mg, 20mg, 40mg)	The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
DRUG	Rosuvastatin (5mg, 20mg, 40mg)	The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
DRUG	Atorvastatin (10mg, 20mg, 40mg)	The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-30
• Completion: 2027-02-20
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

2 sites across 1 country: Pakistan