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OpenTrials
Completed

NCT Number: NCT01042626

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

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.

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Key information

Conditions

Hyperparathyroidism Calcium Metabolism Disorders Endocrine System Diseases Hypercalcemia Metabolic Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Water-Electrolyte Imbalance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

L. Sacco Hospital (Vialba)

Milan, MI, 20157, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use.
  • bone disease of any origin

Treatment and study plan

Oral peptones load

Other

Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Primary outcomes

  1. PTH levels variations

    Time frame: 2 hours

  2. Ionized serum calcium variations

    Time frame: 2 hours

  3. Serum phosphate variations

    Time frame: 2 hours

  4. Serum gastrin variations

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

University of Eastern Piedmont

Other

Collaborators

  • University of Milan

Registry information

Official study title

Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 5, 2010
Registry last updated
Jan 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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