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Clinical Trial Details

Trial ID: L5176
Source ID: NCT02437084
Associated Drug: Atorvastatin
Title: Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02437084/results
Conditions: Hyperlipidemia|Insulin Resistance|Type 2 Diabetes
Interventions: DRUG: Atorvastatin
Outcome Measures: Primary: Steady-state Plasma Glucose (SSPG), Insulin sensitivity measured by SSPG concentration (mg/dL) during the insulin suppression test., baseline, week 9 or 10|Insulin Secretion Rate Area Under the Curve (ISR-AUC), Insulin secretion measured by ISR-AUC (pmol/min x 4 h) during the graded glucose infusion test., baseline, week 9 or 10 | Secondary: Fasting Plasma Glucose, Baseline and end-of-treatment fasting plasma glucose (mg/dL) values represent average of up to 3 measurements for each value (obtained at baseline weeks -2, -1, and 0 and at the end of study at weeks 8, 9, and 10)., 10 weeks|Fasting Plasma Insulin, Baseline and end-of-treatment fasting plasma insulin (mU/L) values represent average of up to 3 measurements for each value (obtained at baseline weeks -2, -1, and 0 and at the end of study at weeks 8, 9, and 10)., 10 weeks|OGTT Glucose AUC, Glucose area under the curve (AUC) (mg/dL x 2 h) measured during a 75-gram oral glucose tolerance test (OGTT)., baseline, week 8|OGTT Insulin AUC, Insulin area under the curve (AUC) (mU/L x 2h) measured during a 75-gram oral glucose tolerance test (OGTT)., baseline, week 8
Sponsor/Collaborators: Sponsor: Stanford University | Collaborators: Doris Duke Charitable Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 115
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-05
Completion Date: 2020-04
Results First Posted: 2021-04-06
Last Update Posted: 2021-04-06
Locations: Stanford University School of Medicine, Stanford, California, 94305, United States
URL: https://clinicaltrials.gov/show/NCT02437084