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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabete Mellitus; Lipid Profile
• Intervention / Treatment: Drug: Rosuvastatin (5mg, 20mg, 40mg); Drug: Atorvastatin (10mg, 20mg, 40mg); Drug: Simvastatin (10mg, 20mg, 40mg)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr Abid Ullah, PhD; Phone Number: +92 302 8533155; Email: abid@sbbu.edu.pk

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Dīr, Khyber Pakhtunkhwa, Pakistan
      • Shaheed Benazir Bhutto University Sheringal Dir Upper
      • Contact: Dr Shujaat Ahmad, PhD; Phone Number: 0944885400; Email: shujat@sbbu.edu.pk
      • Sub-Investigator: Prof Dr. Niaz Ali, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin (5mg, 20mg, 40mg); The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg 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; Other Names: Rosuvastatin
Experimental: Atorvastatin (10mg,20mg, 40mg); The assigned participants will be given Atorvastatin 10mg,20mg, 40mg 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; Other Names: Atorvastatin
Experimental: Simvastatin (10mg, 20mg, 40mg); The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days	Drug: Simvastatin (10mg, 20mg, 40mg); The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days; Other Names: Simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose Measurements	Blood glucose of the subjects will be determined by glucometer in mg/dl	before dosing and 2 days after dosing
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	Before dosing and two days after dosing
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	Before dosing and after two days of Dosing

Collaborators and Investigators

• Sponsor: Shaheed Benazir Bhutto University Sheringal Dir Upper
• Collaborators: Khyber Medical University Peshawar
• Investigators: Principal Investigator: Dr Abid Ullah, PhD, Shaheed Benazir Bhutto University,sheringal

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Amides; Pyrimidines; Hydrocarbons, Halogenated; Pyrroles; Heptanoic Acids; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Lovastatin; Atorvastatin; Rosuvastatin Calcium; Simvastatin
• Other Study ID Numbers: SBBU/PHM-25-33; SBBU/IREC-25-32 (Other Identifier: ShaheedBenazirBhuttoUSheringalDU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study results will be shared in Journals without the participant identifiers.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No