Health TrialsbyHealthPanel

Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers

ConditionsDiabete MellitusLipid Profile
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShaheed Benazir Bhutto University Sheringal Dir Upper

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy volunteers

Non diabetic

blood glucose level (less than140 mg/dl)

Disqualifiers

Participants with a history of diabetes mellitus

With chronic diseases e.g heart disease, kidney disease

participants taking other medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Simvastatin (10mg, 20mg, 40mg)

    Drug

    The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

  • Rosuvastatin (5mg, 20mg, 40mg)

    Drug

    The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

  • Atorvastatin (10mg, 20mg, 40mg)

    Drug

    The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Rosuvastatin (5mg, 20mg, 40mg)Experimental treatment 1 intervention
Group B: Atorvastatin (10mg,20mg, 40mg)Experimental treatment 1 intervention
Group C: Simvastatin (10mg, 20mg, 40mg)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shaheed Benazir Bhutto University Sheringal Dir Upper

Lead sponsor

Khyber Medical University Peshawar

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: