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Acute Regulation of Parathyroid Hormone by Dietary Phosphate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037193
Recruitment Status : Completed
First Posted : May 17, 2002
Last Update Posted : June 24, 2005
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:
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

Condition or disease
Secondary Hyperparathyroidism

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
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Acute Regulation of Parathyroid Hormone by Dietary Phosphate

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  1. Patients 21 years of age or older
  2. Receiving treatment with hemodialysis for at least 90 days.
  3. Serum parathyroid hormone level greater than 200 pg/ml
  4. Serum phosphorus level greater than 4 mg/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00037193

United States, Missouri
Washington University Medical School
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Center for Research Resources (NCRR) Identifier: NCT00037193     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0855
First Posted: May 17, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Additional relevant MeSH terms:
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs