elevated blood pressure Hypertension
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subject is able and willing to sign the Informed Consent Form • Age 18 years or older • WHO performance status 0-2 • Life expectancy >= 12 weeks • mRCC patients in which the treatment of choice is sunitinib
Exclusion criteria
Exclusion criteria: 1) Use of corticosteroids 2) Any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease. 3) Known risk of the patient transmitting HIV, hepatitis B or C via infected blood 4) Patients being treated with oral anticoagulants if to be included in group A.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In group A: forearm vasomotor response to increasing doses of intra-arterially administered acetylcholine and nitroglycerine before and after start of treatment with sunitinib. In group B: insulin sensitivity measured by hyperinsulinemic euglycemic clamp before and after start of treatment with sunitinib. In group C: GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate the effect of sunitinib on body weight and blood pressure 2. To investigate the effect of sunitinib on levels of VEGF, soluble VEGFR, renin, aldosteron, endothelin-1 and renal function in relation to blood pressure 3. To investigate the effect of sunitinib on levels of glucose, total cholesterol, HDL, LDL, triglycerides, insulin, C-peptide, IGF-I, pro-IGF-II, TSH, FT4, leptin, ghrelin, adiponectin, IL-6, IL-18, TNF-a, IFN-γ. 4. To investigate the effect of oral daily sunitinib dosing on insulin requirement in the diabetic subpopulation. | — |
Countries
Netherlands
Outcome results
None listed