Diabete Mellitus, Lipid Profile
Conditions
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.
Interventions
DRUGSimvastatin (10mg, 20mg, 40mg)
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
Sponsors
Shaheed Benazir Bhutto University Sheringal Dir Upper
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
The drugs Rosuvastatin (5mg, 20mg, 40mg), atorvastatin (10mg,20mg, 40mg) and simvastatin(10mg, 20mg, 40mg) will be given orally to the participants of different assigned groups in once daily dosing for two days to assess the effect on blood glucose.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Measurements | before dosing and 2 days after dosing | Blood glucose of the subjects will be determined by glucometer in mg/dl |
| Insulin Levels Determination | 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 | 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 |
Countries
Pakistan
Contacts
CONTACTDr Abid Ullah, PhD
PRINCIPAL_INVESTIGATORDr Abid Ullah, PhD
Shaheed Benazir Bhutto University,sheringal
Outcome results
None listed