Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:12 AM
Study NCT ID:
NCT07378293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers
Sponsor:
Shaheed Benazir Bhutto University Sheringal Dir Upper
Organization:
Study Overview
Official Title:
Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
[Statins]
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SBBU/IREC-25-32 | OTHER | ShaheedBenazirBhuttoUSheringalDU | View |