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Clinical Trials/NCT00961701
NCT00961701TerminatedNot Applicable

Atherogenic Lipoprotein Phenotype and LDL Size and Subclasses in Patients With Primary Hyperparathyroidism

HaEmek Medical Center, Israel1 site in 1 country100 target enrollmentStarted: October 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
100
Locations
1

Study Overview

Brief Summary

Severe Primary hyperparathyroidism (PHP) has been associated with increased cardiovascular morbidity and mortality. Hypertension, dyslipidemia and impaired glucose tolerance were demonstrated in severe PHP, with improvement after surgery in these variables. Recent evidence suggests that the 'quality' rather than only the 'quantity' of low-density lipoprotein (LDL)-cholesterol exerts a direct influence on the cardiovascular risk. Thus, the proposed study protocol is intended to evaluate lipoprotein phenotype and LDL size and subclasses in patients with primary hyperparathyroidism.

Detailed Description

Severe traditional PHP has been associated with increased cardiovascular morbidity and mortality with an increase in acute MI prior to surgery.PHP is associated with increased prevalence of left ventricular hypertrophy, independent of blood pressure. Also prevalent in PHP, are valvular and myocardial calcifications as well as diastolic filling impairment, with a significant correlation with serum calcium and PTH levels.

Hypertension, dyslipidemia and impaired glucose metabolism were demonstrated in severe PHP, with improvement after surgery in these variables.Glucose tolerance test performed in patients with PHP revealed that 51% had impaired glucose tolerance, 34% had diabetes mellitus and 17% had impaired fasting glucose values. After successful parathyroidectomy fasting and 2-h plasma glucose falls significantly. Others have demonstrated hyperinsulinemia and impaired glucose tolerance without normalization after parathyroidectomy.

Most of the literature showing an increased cardiovascular risk is in those patients with more severe PHP .Patients with mild PHP had higher serum cholesterol, triglycerides, glucose, urate and hemoglobin values compared with controls.Also, moderate to severe vitamin D deficiency is a risk factor for developing cardiovascular disease especially in patients with hypertension.

Atherosclerosis is a diffuse disease formerly considered a lipid storage disease, which actually involves an ongoing inflammatory response. Elevated circulating levels of acute phase proteins, cytokines, and cell adhesion molecules indicate that inflammatory processes are occurring systemically . C-reactive protein [CRP] and the presence of metabolic syndrome were interrelated and were highly predictive for cardiovascular disease. Hyperinsulinemia was proposed as the common factor of all the traditional risk factors for cardiovascular disease, and insulin resistance is recognized as a chronic low-level inflammatory state.Although various inflammatory markers were individually significantly related to future cardiovascular disease risk, they added very little additional prognostic information to the traditional markers.

Recently, we have shown that greater probability of metabolic syndrome and insulin resistance were observed in patients with severe PHP. Serum calcium is a predictor of these cardiovascular risk factors.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with primary hyperparathyroidism

Exclusion Criteria

  • pregnant women
  • patient taking hypolipidemic drugs
  • patients with known cardiovascular, peripheral or cerebral atherosclerotic disease.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

avraham ishay

Dr

HaEmek Medical Center, Israel

Study Sites (1)

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