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Effects of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01057732
First received: January 25, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition
Primary Hyperparathyroidism

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Parathyroidectomy on Cardiovascular Risk Factors in Patients With Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Biospecimen Retention:   Samples Without DNA

serum, urine


Enrollment: 76
Study Start Date: January 2005
Study Completion Date: December 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
primary hyperparathyroidism
patients with primary hyperparathyroidism
controls
subjects without primary hyperparathyroidism

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with Primary hyperparathyroidism referred to Endocrine clinic. Controls recruited in community-based health centers.

Criteria

Inclusion Criteria:

  • Patients with primary hyperparthyroidism

Exclusion Criteria:

  • Individuals with known diabetes mellitus,coronary heart disease, stroke
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057732

Locations
Israel
Endocrine Institute, Haemek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Avraham Ishay, Haemek Medical Center, Afula, Israel
ClinicalTrials.gov Identifier: NCT01057732     History of Changes
Other Study ID Numbers: 3630405
Study First Received: January 25, 2010
Last Updated: January 25, 2010
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Endocrine System Diseases
Parathyroid Diseases

ClinicalTrials.gov processed this record on November 25, 2014