We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042626
First Posted: January 5, 2010
Last Update Posted: January 5, 2010
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.
Collaborator:
University of Milan
Information provided by:
University of Eastern Piedmont
  Purpose

The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum calcium levels have different responses in the calcium regulating hormonal handling compared to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy subjects.

The differences will be evaluated with oral peptones load and subsequent blood samples collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels will be evaluated.


Condition Intervention
Hyperparathyroidism Hypercalcemia Other: Oral peptones load

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University of Eastern Piedmont:

Primary Outcome Measures:
  • PTH levels variations [ Time Frame: 2 hours ]
  • Ionized serum calcium variations [ Time Frame: 2 hours ]
  • Serum phosphate variations [ Time Frame: 2 hours ]
  • Serum gastrin variations [ Time Frame: 2 hours ]

Enrollment: 60
Study Start Date: July 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normocalcemic Hyperparathyroidism Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
Experimental: Hypercalcemic Hyperparathyroidism Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
Active Comparator: Healthy subjects Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. normocalcemic hyperparathyroidism

    • presence of high serum levels of intact PTH
    • serum ionized calcium levels in the high normality range
  2. hypercalcemic hyperparathyroidism

    • presence of high serum levels of intact PTH
    • high serum ionized calcium levels

Exclusion Criteria:

  1. potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use.
  2. bone disease of any origin
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01042626


Locations
Italy
L. Sacco Hospital (Vialba)
Milano, MI, Italy, 20157
Sponsors and Collaborators
University of Eastern Piedmont
University of Milan
  More Information

Publications:
Responsible Party: Maurizio Bevilacqua, L. Sacco Hospital (Vialba)
ClinicalTrials.gov Identifier: NCT01042626     History of Changes
Other Study ID Numbers: NO012010
First Submitted: January 4, 2010
First Posted: January 5, 2010
Last Update Posted: January 5, 2010
Last Verified: January 2010

Keywords provided by University of Eastern Piedmont:
Receptors, Calcium sensing
Parathyroid Hormone

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Hypercalcemia
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance