An observational study in Aging, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by Peking University Third Hospital · Observational
The goal of this observational study aims to reveal the pharmacokinetics of clinical probes and characteristics of endogenous biomarkers for drug-metabolizing enzymes and transporters in Chinese older adults and old older adults, to analyze their correlation with frailty, and to explore the exosome characteristics in this population.
This study is a non-intervention observational study in Chinese older adults and will not interfere with the routine medical treatment. 6-10 mL whole blood and 20 mL urine samples (only applicable for patients taking meropenem and metformin) will be collected from eligible subjects according to medical routine blood collection time. Concentration of clinical probes and respective metabolites (when required), endogenous biomarkers, genotype information of drug-metabolizing enzymes and transporters, and the exosome characteristics will be quantified or measured.
Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inpatients aged 60-74 years old (older adults group) and ≥75 years old (old older adults group) with stable underlying disease, takes any one or more of the following clinical probes: omeprazole/rabeprazole/pantoprazole/metoprolol/carvedilol/rivaroxaban/amlodipine/finasteride/simvastatin/meropenem/atorvastatin/rosuvastatin/metformin.
Exclusion Criteria:
Drugs that may affect the study were consumed within 1 week prior to screening:
Aged 60-74 years old, takes omeprazole or rabeprazole or pantoprazole or metoprolol or carvedilol or amlodipine or finasteride or simvastatin or rivaroxaban or meropenem or atorvastatin or rosuvastatin or metformin
Drug: Clinical probes
Aged \>75 years old, takes omeprazole or rabeprazole or pantoprazole or metoprolol or carvedilol or amlodipine or finasteride or simvastatin or rivaroxaban or meropenem or atorvastatin or rosuvastatin or metformin
Drug: Clinical probes
Inpatients taking one or more clinical probes of CYP2C19 (omeprazole, rabeprazole, pantoprazole), CYP2D6 (metoprolol, carvedilol), CYP3A4 (rivaroxaban, finasteride, amlodipine, simvastatin), OAT (meropenem), OATP1B1 (atorvastatin, rosuvastatin) and OCT (metformin) will be included in the study.
Concentration of clinical probes in plasma
Plasma concentration of clinical probes and the respective metabolites (when required) will be quantified and measured by LC-MS/MS or HPLC
Time frame: Sampling will be performed according to routine medical follow-up, which should be no less than 3 samples over the period of one year
Concentration of clinical probes in urine
Urine concentration of meropenem and metformin will be quantified and measured by LC-MS/MS or HPLC
Time frame: Urine samples will be collected at any administration intervals, which should be no less than 1 sample over the period of one year
Level of endogenous biomarker
The level of endogenous biomarker (Dihydroxyeicosatrienoic acids, DHETs, 4β-hydroxycholesterol/cholesterol ratio, 4β-OHC/CHO, pyridoxic acids, PDA, Coproporphyrin, CP) will be quantified and measured by LC-MS/MS or HPLC or ELISA
Time frame: sampling will be performed according to routine medical follow-up, which should be no less than 3 samples over the period of one year
Plan to share: No
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Peking University Third Hospital