Phase
Condition
Focal Segmental Glomerulosclerosis
Kidney Disease
Nephropathy
Treatment
Placebo
Gonadotropin-Releasing Hormone Agonist
Androgen receptor (AR) inhibitor
Clinical Study ID
Ages > 40 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
-age 40+ years;
resting blood pressure <140/90 mmHg;
fasted blood glucose <126 mg/dL;
testosterone ≥400 ng/dL;
sedentary to recreationally active;
nonsmokers;
healthy as determined by medical history, physical exam, blood and urine chemistriesand resting and exercise ECG during a physician supervised graded exercise treadmilltest OR recent diagnosis of non-metastatic prostate cancer with plans to undergoandrogen deprivation therapy;
PSA <4.00 ng/dL if in the non-cancer group;
Gleason Score ≤7 if in the prostate cancer group;
no use of medications that might influence cardiovascular function (e.g.,antihypertensives, lipid-lowering medications);
willing and able to be on GnRHagonist and AR inhibitor;
not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications,or willing to stop use for four weeks prior to the start of the study;
not using exogenous sex hormones for at least one year
Exclusion
Exclusion Criteria:
-acute liver disease;
chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g ofproteinuria
pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizuredisorder;
diabetes, active or chronic infection, disease that affects the nervous system;
Gleason Score ≥8;
thyroid dysfunction, defined as ultrasensitive TSH <0.5 or >5.0 mU/L, volunteerswith abnormal TSH values will be re-considered for participation after follow-upevaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
tobacco use within the previous 12 months
Study Design
Connect with a study center
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United StatesActive - Recruiting
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