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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Glucose Measurements', 'timeFrame': 'before dosing and 2 days after dosing', 'description': 'Blood glucose of the subjects will be determined by glucometer in mg/dl'}, {'measure': 'Insulin Levels Determination', 'timeFrame': 'Before dosing and two days after dosing', 'description': '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'}, {'measure': 'C- Peptide determination', 'timeFrame': 'Before dosing and after two days of Dosing', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabete Mellitus', 'Lipid Profile']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n* Non diabetic\n* blood glucose level (less than140 mg/dl)\n\nExclusion Criteria:\n\n* Participants with a history of diabetes mellitus\n* With chronic diseases e.g heart disease, kidney disease\n* participants taking other medications'}, 'identificationModule': {'nctId': 'NCT07378293', 'acronym': '[Statins]', 'briefTitle': 'Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Benazir Bhutto University Sheringal Dir Upper'}, 'officialTitle': 'Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial', 'orgStudyIdInfo': {'id': 'SBBU/PHM-25-33'}, 'secondaryIdInfos': [{'id': 'SBBU/IREC-25-32', 'type': 'OTHER', 'domain': 'ShaheedBenazirBhuttoUSheringalDU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin (5mg, 20mg, 40mg)', 'description': 'The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days', 'interventionNames': ['Drug: Rosuvastatin (5mg, 20mg, 40mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Atorvastatin (10mg,20mg, 40mg)', 'description': 'The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days', 'interventionNames': ['Drug: Atorvastatin (10mg, 20mg, 40mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin (10mg, 20mg, 40mg)', 'description': 'The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days', 'interventionNames': ['Drug: Simvastatin (10mg, 20mg, 40mg)']}], 'interventions': [{'name': 'Simvastatin (10mg, 20mg, 40mg)', 'type': 'DRUG', 'otherNames': ['Simvastatin'], 'description': 'The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days', 'armGroupLabels': ['Simvastatin (10mg, 20mg, 40mg)']}, {'name': 'Rosuvastatin (5mg, 20mg, 40mg)', 'type': 'DRUG', 'otherNames': ['Rosuvastatin'], 'description': 'The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days', 'armGroupLabels': ['Rosuvastatin (5mg, 20mg, 40mg)']}, {'name': 'Atorvastatin (10mg, 20mg, 40mg)', 'type': 'DRUG', 'otherNames': ['Atorvastatin'], 'description': 'The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days', 'armGroupLabels': ['Atorvastatin (10mg,20mg, 40mg)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dīr', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'contacts': [{'name': 'Dr Shujaat Ahmad, PhD', 'role': 'CONTACT', 'email': 'shujat@sbbu.edu.pk', 'phone': '0944885400'}, {'name': 'Prof Dr. Niaz Ali, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shaheed Benazir Bhutto University Sheringal Dir Upper', 'geoPoint': {'lat': 35.2074, 'lon': 71.8768}}, {'city': 'Dīr', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Shaheed Benazir Bhutto University Sheringal Dir Upper', 'geoPoint': {'lat': 35.2074, 'lon': 71.8768}}], 'centralContacts': [{'name': 'Dr Abid Ullah, PhD', 'role': 'CONTACT', 'email': 'abid@sbbu.edu.pk', 'phone': '+92 302 8533155'}], 'overallOfficials': [{'name': 'Dr Abid Ullah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaheed Benazir Bhutto University,sheringal'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'ipdSharing': 'YES', 'description': 'The study results will be shared in Journals without the participant identifiers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaheed Benazir Bhutto University Sheringal Dir Upper', 'class': 'OTHER'}, 'collaborators': [{'name': 'Khyber Medical University Peshawar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Dr Abid Ullah', 'investigatorAffiliation': 'Shaheed Benazir Bhutto University Sheringal Dir Upper'}}}}