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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Shaheed Benazir Bhutto University Sheringal Dir Upper
Dīr, Khyber Pakhtunkhwa, Pakistan
Shaheed Benazir Bhutto University Sheringal Dir Upper
Dīr, Khyber Pakhtunkhwa, Pakistan
Blood Glucose Measurements
Blood glucose of the subjects will be determined by glucometer in mg/dl
Time frame: before dosing and 2 days after dosing
Insulin Levels Determination
Blood insulin levels of each participants will be checked by using human insulin ELISA kit 96 wells on respective peak plasma concentration of respective statin
Time frame: Before dosing and two days after dosing
C- Peptide determination
Blood samples approx. 4 mL will be taken from the participants to check C- Peptide levels by using human peptide C ELISA kit on respective peak plasma concentration of respective statin
Time frame: Before dosing and after two days of Dosing
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