Primary HyperparathyroidismNCT01057732
Effects of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism
An observational study of Primary Hyperparathyroidism, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hyperparathyroidism
- How many people
- 76 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2005to Dec 2006
- 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 80 years
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Primary hyperparathyroidism referred to Endocrine clinic. Controls recruited in community-based health centers.
Who may be able to join
- Patients with primary hyperparthyroidism
Who cannot join
- Individuals with known diabetes mellitus,coronary heart disease, stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Parathyroidectomy on Cardiovascular Risk Factors in Patients With Primary Hyperparathyroidism
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.
Read the 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.
- Conditions
- Primary Hyperparathyroidism
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| primary hyperparathyroidism | patients with primary hyperparathyroidism | |
| controls | subjects without primary hyperparathyroidism |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2005
- Primary completionJun 2006
- Study completionDec 2006
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-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057732
- Sponsor's protocol ID
- 3630405
- Status last verified
- Jan 2010
- First submitted
- 25 Jan 2010
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parathyroidectomy on Cardiovascular Risk Factors in Patients With Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT01057732
- Acronym / sponsor ID
- 3630405
- Conditions
- Primary Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 27 Jan 2010 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary hyperparathyroidism | – | –patients with primary hyperparathyroidism |
| controls | – | –subjects without primary hyperparathyroidism |
Who may qualify
- Ages
- 18 to 80 years
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Primary hyperparathyroidism referred to Endocrine clinic. Controls recruited in community-based health centers.
Key inclusion criteria (1 listed)
- Patients with primary hyperparthyroidism
Key exclusion criteria (1 listed)
- Individuals with known diabetes mellitus,coronary heart disease, stroke
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 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: finished, as of the sponsor's last update on 27 Jan 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 27 Jan 2010.