Effects of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism

Primary Hyperparathyroidism Clinical Trial

Official title:

The Effect of Parathyroidectomy on Cardiovascular Risk Factors in Patients With Primary Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057732
• Other study ID #: 3630405
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: January 25, 2010
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2010
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Primary hyperparathyroidism (PHPT) is associated with increased cardiovascular morbidity. The benefit of surgical treatment in this respect is unclear.

This study was performed to evaluate the impact of parathyroidectomy (PTX) on cardiovascular risk profile.

Description:

Patients with primary hyperparathyroidism (PHPT) have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of cardiovascular disease in PHPT is not well understood and probably multifactorial. Functional or structural alterations of vascular endothelial and smooth muscle cells may impair the vascular reactivity and lead to accelerated atherogenesis. Several cardiovascular risk factors such as obesity, hypertension, insulin resistance and hyperlipidemia are more prevalent in PHPT compared with controls.Patients with severe form of PHPT had a greater probability of metabolic syndrome (MS) and insulin resistance than patients with mild PHPT and eucalcemic subjects. Although the excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. Some studies suggest that hypertension, dyslipidemia, and derangement of glucose metabolism improve after removal of overactive parathyroid tissue. Others have shown that cardiovascular risk markers remained unaltered after parathyroidectomy (PTX).

The aim of this study was to evaluate whether successful PTX is associated with decreased cardiovascular risk. We investigated indices of metabolic syndrome and insulin resistance as well as various cardiovascular risk factors in patients with manifest PHPT before and one year after successful PTX.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with primary hyperparthyroidism

Exclusion Criteria:

• Individuals with known diabetes mellitus,coronary heart disease, stroke

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Locations

Country	Name	City	State
Israel	Endocrine Institute, Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel,