Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers

NCT07378293 — Phase 1, Not yet recruiting, 100 participants, Shaheed Benazir Bhutto University Sheringal Dir Upper

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Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial

Registry	NCT07378293, acronym [Statins]
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	100 (Estimated)
Sponsor	Shaheed Benazir Bhutto University Sheringal Dir Upper (Other); collaborators: Khyber Medical University Peshawar
Conditions	Diabete Mellitus, Lipid Profile
Interventions	Simvastatin (10mg, 20mg, 40mg), Rosuvastatin (5mg, 20mg, 40mg), Atorvastatin (10mg, 20mg, 40mg) (Drug)
Dates	start 2026-03-01 (estimated), primary completion 2026-12-30 (estimated), completion 2027-02-20 (estimated), first posted 2026-01-30, last updated 2026-01-30
Locations	2 sites in Pakistan

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Rosuvastatin (5mg, 20mg, 40mg)	Experimental	Drug: Rosuvastatin (5mg, 20mg, 40mg)	The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days
Atorvastatin (10mg,20mg, 40mg)	Experimental	Drug: Atorvastatin (10mg, 20mg, 40mg)	The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days
Simvastatin (10mg, 20mg, 40mg)	Experimental	Drug: Simvastatin (10mg, 20mg, 40mg)	The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days

Simvastatin (10mg, 20mg, 40mg) (Drug), also known as Simvastatin: The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Rosuvastatin (5mg, 20mg, 40mg) (Drug), also known as Rosuvastatin: The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Atorvastatin (10mg, 20mg, 40mg) (Drug), also known as Atorvastatin: The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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

+Locations (2)

Facility	City	Country	Status
Shaheed Benazir Bhutto University Sheringal Dir Upper	Dīr, Khyber Pakhtunkhwa	Pakistan
Shaheed Benazir Bhutto University Sheringal Dir Upper	Dīr, Khyber Pakhtunkhwa	Pakistan

+Investigators

Dr Abid Ullah, PhD, Principal investigator, Shaheed Benazir Bhutto University,sheringal