Impact of Parathyroidectomy on Renal Function
- Conditions
- Primary Hyperparathyroidism
- Registration Number
- NCT04798092
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.
- Detailed Description
Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.
Criteria are detailled in "Outcomes measures"
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia
- patients on dialysis
- GFR < 15 ml/min
- renal graft
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in renal function preoperative, postoperative at 3, 6, and 12 months glomerular filtration rate (CKD in mL/min)
- Secondary Outcome Measures
Name Time Method Change in vitamin D preoperative, postoperative at 3, 6, and 12 months Blood vitamine D level (in ng/mL)
Change in urinary calcium preoperative, postoperative at 3, 6, and 12 months Urine calcium level (in mg/24h)
Change in insulin preoperative, postoperative at 3, 6, and 12 months Fasting blood insuline level (in mUI/L)
Change in glycemia preoperative, postoperative at 3, 6, and 12 months Fasting blood glucose level (in g/L)
Change in osteocalcin preoperative, postoperative at 3, 6, and 12 months Blood osteocalcin level (in ng/mL)
Change in bone alkaline phosphatases preoperative, postoperative at 3, 6, and 12 months Blood bone alkaline phosphatases level (in microgr/L)
Change in aldosterone preoperative, postoperative at 3, 6, and 12 months Blood aldosterone level (in pg/mL)
Change in renin preoperative, postoperative at 3, 6, and 12 months Blood active renin (in pg/mL)
Change in total cholesterol preoperative, postoperative at 3, 6, and 12 months Blood total cholesterol (in gr/L)
Change in calcium preoperative, postoperative at 3, 6, and 12 months Blood calcium level (in mg/L)
Change in parathormone preoperative, postoperative at 3, 6, and 12 months Blood parathormone level (in ng/dL)
Change in HDL cholesterol preoperative, postoperative at 3, 6, and 12 months Blood HDL Cholesterol (in gr/L)
Change in LDL cholesterol preoperative, postoperative at 3, 6, and 12 months Blood LDL Cholesterol (in gr/L)
Change in triglycerides preoperative, postoperative at 3, 6, and 12 months Blood triglycerides (in gr/L)
CAC scoring on CT scan preoperative CAC score (actual value)
Trial Locations
- Locations (1)
CHRU Nancy
🇫🇷Vandœuvre-lès-Nancy, Lorraine, France