- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037193
Acute Regulation of Parathyroid Hormone by Dietary Phosphate
June 23, 2005 updated by: National Center for Research Resources (NCRR)
Patients with end stage renal disease often have secondary hyperparathyroidism due to high phosphorus and low calcium levels in the blood.
Preliminary animal studies and our initial human study indicate that the parathyroid hormone levels may change quickly based on the ingestion of phosphorus, prior to any change in the blood levels of calcium or phosphorus.
This follow-up study will attempt to determine if the effect is independent of an increase in the blood glucose level.
If so, this would suggest an as yet unidentified gastrointestinal receptor that mediates parathyroid hormone levels.
This may affect the timing of administration and the type of phosphate binder used in treating patients with secondary hyperparathyroidism.
The knowledge that parathyroid hormone levels can change acutely may also affect the recommended timing of blood samples
Study Overview
Status
Completed
Conditions
Detailed Description
This study is observational and no drugs or other interventions will be used.
The population targeted in this study will be adult patients already on chronic hemodialysis with a diagnosis of secondary hyperparathyroidism.
Experimental design will involve the use of a glucose clamp to maintain a constant, mild increase in blood glucose levels.
Frequent, scheduled lab tests will be obtained during the period of hyperglycemia to evaluate phosphorous, calcium, and glucose levels and the relationship of any change in their values to changes in the parathyroid hormone level.
The primary outcome will be to evaluate for any change in the parathyroid hormone level in the presence of hyperglycemia and to compare these results to that of our initial study
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Patients 21 years of age or older
- Receiving treatment with hemodialysis for at least 90 days.
- Serum parathyroid hormone level greater than 200 pg/ml
- Serum phosphorus level greater than 4 mg/dl
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
May 16, 2002
First Submitted That Met QC Criteria
May 16, 2002
First Posted (Estimate)
May 17, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
December 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCRR-M01RR00036-0855
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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