Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Simvastatin (10mg, 20mg, 40mg), Rosuvastatin (5mg, 20mg, 40mg), Atorvastatin (10mg, 20mg, 40mg).
- Who it may be relevant to
- Registry conditions: Diabete Mellitus, Lipid Profile. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- Blood Glucose Measurements [Time frame: before dosing and 2 days after dosing]
- Insulin Levels Determination [Time frame: Before dosing and two days after dosing]
- C- Peptide determination [Time frame: Before dosing and after two days of Dosing]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Pakistan · 2 centers
- Shaheed Benazir Bhutto University Sheringal Dir Upper — Dīr
- Shaheed Benazir Bhutto University Sheringal Dir Upper — Dīr
Identifiers
NCT: NCT07378293 · SBBU/PHM-25-33 · SBBU/IREC-25-32