Secondary HyperparathyroidismNCT03137316
Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy
An observational study of Secondary Hyperparathyroidism and Diabetic Nephropathies, run by Benha University.
Trial summary
The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Diabetic Nephropathies
- What is being tested?
- intact parathyroid hormone level
- How many people
- 437 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 437 diabetic patients were enrolled in this study from 864 diabetic patients who attended diabetes and nephrology outpatient clinics in our tertiary care hospital in Jeddah from Jan 2014 to Feb 2017.
Who may be able to join
- [1] Age was above 18 years, [2] Patient had diabetic nephropathy which was diagnosed based on the presence of urinary albumin/creatinine ratio (uACR) ≥ 30 mg/gm ± 24 hours' urinary protein measurement ≥ 300 mg/day
Who cannot join
- [1] patients were already receiving cinacalcet and/or [2] patients had undergone neck surgery for parathyroidectomy.
About this study
The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy.
- Being tested
- intact parathyroid hormone level
- Medical subject headings
- Hyperparathyroidism, Secondary, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intact parathyroid hormone levelDiagnostic test
obtain intact parathyroid hormone level from patients records.
What is being measured
The primary outcome is the main question the study is designed to answer.
intact parathyroid level
intact parathyroid level
Measured: within 1 hour from attending in the clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Jan 2014
- Primary completion28 Feb 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137316
- Sponsor's protocol ID
- BN-0418
- Status last verified
- May 2017
- First submitted
- 28 Apr 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03137316
- Acronym / sponsor ID
- BN-0418
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 437 diabetic patients were enrolled in this study from 864 diabetic patients who attended diabetes and nephrology outpatient clinics in our tertiary care hospital in Jeddah from Jan 2014 to Feb 2017.
Key inclusion criteria (1 listed)
- [1] Age was above 18 years, [2] Patient had diabetic nephropathy which was diagnosed based on the presence of urinary albumin/creatinine ratio (uACR) ≥ 30 mg/gm ± 24 hours' urinary protein measurement ≥ 300 mg/day
Key exclusion criteria (1 listed)
- [1] patients were already receiving cinacalcet and/or [2] patients had undergone neck surgery for parathyroidectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intact parathyroid hormone levelobtain intact parathyroid hormone level from patients records. | Diagnostic test | – |
Primary outcome
intact parathyroid level
Time frame: within 1 hour from attending in the clinic
intact parathyroid level
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 2 May 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Hyperparathyroidism and Diabetic Nephropathies, run by Benha University.
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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
intact parathyroid level (time frame: within 1 hour from attending in the clinic). It is what the study was designed to measure, not a finding.
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 2 May 2017.