Trial record 10 of 44 for:    "hyperparathyroidism-jaw tumor syndrome" OR "Primary Hyperparathyroidism" OR "Hyperparathyroidism, Primary"

Lipids Profile in Primary Hyperparathyroidism (LPHP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University of Palermo
University of Zurich
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00961701
First received: August 18, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition
Primary Hyperparathyroidism

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Atherogenic Lipoprotein Phenotype and LDL Size and Subclasses in Patients With Primary Hyperparathyroidism

Resource links provided by NLM:


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

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

Recent evidence suggests that the 'quality' rather than only the 'quantity' of LDL exerts a direct influence on the cardiovascular risk. LDL comprises multiple distinct subclasses that differ in size, density, physicochemical composition, metabolic behaviour and atherogenicity. There are at least four major subspecies of LDL (e.g. large LDL-I, medium LDL-II, small LDL-III, very small LDL-IV) and the predominance of small dense LDL has been accepted as an emerging cardiovascular risk factor .

Thus, the proposed study protocol is intended to evaluate lipoprotein phenotype and LDL size and subclasses in patients with primary hyperparathyroidism.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients followed at the Endocrine Institute

Criteria

Inclusion Criteria:

  • Patients with primary hyperparathyroidism

Exclusion Criteria:

  • pregnant women
  • patient taking hypolipidemic drugs
  • patients with known cardiovascular, peripheral or cerebral atherosclerotic disease.
  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: NCT00961701

Contacts
Contact: Avraham Ishay, MD 972-4-6495556 ext 5556 ishay_av@netvision.net.il

Locations
Israel
Endocrine Institute , Haemek Medical Center Not yet recruiting
Afula, Israel, 18101
Contact: Avraham Ishay, MD    972-4-6495556 ext 5556    ishay_av@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
University of Palermo
University of Zurich
Investigators
Study Director: Rafael Luboshitzky, MD Endocrine Institute, Haemek Medical Center, Afula, Israel
Study Chair: Manfredi Rizzo, MD University of Palermo
Study Chair: Giatgen Spinas, MD University of Zurich
Study Chair: Kaspar Berneis, MD University of Zurich
  More Information

No publications provided

Responsible Party: Dr Avraham Ishay, Endocrine Institute, Haemek Medical Center, Afula Israel
ClinicalTrials.gov Identifier: NCT00961701     History of Changes
Other Study ID Numbers: 0097.09EMC
Study First Received: August 18, 2009
Last Updated: August 18, 2009
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on July 20, 2014