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| ID | Type | Description | Link |
|---|---|---|---|
| SBBU/IREC-25-32 | Other Identifier | ShaheedBenazirBhuttoUSheringalDU |
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| Name | Class |
|---|---|
| Khyber Medical University Peshawar | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin (5mg, 20mg, 40mg) | Experimental | The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days |
|
| Atorvastatin (10mg,20mg, 40mg) | Experimental | The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days |
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| Simvastatin (10mg, 20mg, 40mg) | Experimental | The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin (10mg, 20mg, 40mg) | Drug | The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Abid Ullah, PhD | Contact | +92 302 8533155 | abid@sbbu.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Dr Abid Ullah, PhD | Shaheed Benazir Bhutto University,sheringal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaheed Benazir Bhutto University Sheringal Dir Upper | Dīr | Khyber Pakhtunkhwa | Pakistan |
The study results will be shared in Journals without the participant identifiers.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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The drugs Rosuvastatin (5mg, 20mg, 40mg), atorvastatin (10mg,20mg, 40mg) and simvastatin(10mg, 20mg, 40mg) will be given orally to the participants of different assigned groups in once daily dosing for two days to assess the effect on blood glucose.
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The PI will give the assigned medication to each participant according to randomization and allocation. All the personnel involved in the study will be kept blind.
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| 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 |
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| Shaheed Benazir Bhutto University Sheringal Dir Upper | Dīr | Khyber Pakhtunkhwa | Pakistan |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |