Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Blood Glucose Measurements
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
The PI will give the assigned medication to each participant according to randomization and allocation. All the personnel involved in the study will be kept blind.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy volunteers
- •Non diabetic
- •blood glucose level (less than140 mg/dl)
Exclusion Criteria
- •Participants with a history of diabetes mellitus
- •With chronic diseases e.g heart disease, kidney disease
- •participants taking other medications
Arms & Interventions
Rosuvastatin (5mg, 20mg, 40mg)
The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days
Intervention: Rosuvastatin (5mg, 20mg, 40mg) (Drug)
Atorvastatin (10mg,20mg, 40mg)
The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days
Intervention: Atorvastatin (10mg, 20mg, 40mg) (Drug)
Simvastatin (10mg, 20mg, 40mg)
The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days
Intervention: Simvastatin (10mg, 20mg, 40mg) (Drug)
Outcomes
Primary Outcomes
Blood Glucose Measurements
Time Frame: before dosing and 2 days after dosing
Blood glucose of the subjects will be determined by glucometer in mg/dl
Insulin Levels Determination
Time Frame: Before dosing and two days after dosing
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
C- Peptide determination
Time Frame: Before dosing and after two days of Dosing
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Abid Ullah
Lecturer
Shaheed Benazir Bhutto University Sheringal Dir Upper