Primary HyperparathyroidismLPHPNCT00961701
Lipids Profile in Primary Hyperparathyroidism
An observational study of Primary Hyperparathyroidism, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Hyperparathyroidism
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed at the Endocrine Institute
Who may be able to join
- Patients with primary hyperparathyroidism
Who cannot join
- pregnant women
- patient taking hypolipidemic drugs
- patients with known cardiovascular, peripheral or cerebral atherosclerotic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atherogenic Lipoprotein Phenotype and LDL Size and Subclasses in Patients With Primary Hyperparathyroidism
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.
Read the 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.
- Conditions
- Primary Hyperparathyroidism
- Medical subject headings
- Hyperparathyroidism, Primary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2016 (estimated)
Why it stopped: sample size was not enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Palermo, University of Zurich
- Responsible party
- Principal investigator, avraham ishay, HaEmek Medical Center, Israel
- Investigators
- Rafael Luboshitzky, MD, Study director, Endocrine Institute, Haemek Medical Center, Afula, IsraelManfredi Rizzo, MD, Study chair, University of PalermoGiatgen Spinas, MD, Study chair, University of ZurichKaspar Berneis, MD, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961701
- Sponsor's protocol ID
- 0097.09EMC
- Acronym
- LPHP
- Status last verified
- Sep 2016
- First submitted
- 18 Aug 2009
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherogenic Lipoprotein Phenotype and LDL Size and Subclasses in Patients With Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT00961701
- Acronym / sponsor ID
- LPHP / 0097.09EMC
- Conditions
- Primary Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sample size was not enrolled
- Enrolment
- 100 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- University of Palermo, University of Zurich
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at the Endocrine Institute
Key inclusion criteria (1 listed)
- Patients with primary hyperparathyroidism
Key exclusion criteria (3 listed)
- pregnant women
- patient taking hypolipidemic drugs
- patients with known cardiovascular, peripheral or cerebral atherosclerotic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: sample size was not enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Luboshitzky, MD study director
Endocrine Institute, Haemek Medical Center, Afula, Israel
Manfredi Rizzo, MD study chair
University of Palermo
Giatgen Spinas, MD study chair
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sample size was not enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016; AzTrials last refreshed its copy on 29 Oct 2026.