Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers ([Statins])

Shaheed Benazir Bhutto University Sheringal Dir Upper

Status and phase: Begins enrollment this month; Phase 1

Conditions: Lipid Profile; Diabete Mellitus

Treatments: Drug: Simvastatin (10mg, 20mg, 40mg); Drug: Atorvastatin (10mg, 20mg, 40mg); Drug: Rosuvastatin (5mg, 20mg, 40mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT07378293

SBBU/PHM-25-33

SBBU/IREC-25-32 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups

Rosuvastatin (5mg, 20mg, 40mg)

Experimental group

Description:

The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days

Treatment:

Drug: Rosuvastatin (5mg, 20mg, 40mg)

Atorvastatin (10mg,20mg, 40mg)

Experimental group

Description:

The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days

Treatment:

Drug: Atorvastatin (10mg, 20mg, 40mg)

Simvastatin (10mg, 20mg, 40mg)

Experimental group

Description:

The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days

Treatment:

Drug: Simvastatin (10mg, 20mg, 40mg)