Grasping the Underlying Mechanisms of drug Disposition and Receptor Occupancy by Positron-emission tomography Studies (GUMDROPS): A feasibility study for the use of 11C-telmisartan to quantify individual differences in target-site exposure in diabetes patients;

Grasping the Underlying Mechanisms of drug Disposition and Receptor Occupancy by Positron-emission tomography Studies (GUMDROPS): A feasibility study for the use of 11C-telmisartan to quantify individual differences in target-site exposure in diabetes patients; - GUMDROPS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46612

Enrollment

Registered

2018-12-20

Start date

2019-01-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Main inclusion criteria are; - Type 2 diabetes - urinary albumin:creatinine ratio (UACR)> 1.7 mg/mmol - Age * 45 years * 70 years - Written informed consent

Exclusion criteria

Exclusion criteria: Main exclusion criteria are; - Pregnant women and women of child-bearing potential who are not using reliable contraception; - Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV)

Design outcomes

Primary

Measure	Time frame
The main study parameters are dynamic PET data and images and radiation count measurement, and free plasma concentrations of telmisartan and its metabolite telmisartan-glucoronide.	—

Secondary

Measure	Time frame
The secondary study parameters are GFR and UACR.	—

Countries

Netherlands

Outcome results