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Parathyroid Hormone (PTH) Homeostasis in Bartter Syndrome

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ClinicalTrials.gov Identifier: NCT01021280
Recruitment Status : Unknown
Verified June 2012 by Daniel Landau MD, Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 26, 2009
Last Update Posted : June 14, 2012
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by (Responsible Party):
Daniel Landau MD, Soroka University Medical Center

Brief Summary:

Parathyroid hormone (PTH) gland calcium sensing receptor (CASR) regulates PTH secretion. CASR is also expressed in nephron thick ascending limb (TAL). Bartter syndrome (BS), a normotensive hypokalemic tubulopathy, may be due to mutations in different TAL channels, including the potassium channel ROMK. Mutations in CASR may also cause BS through its effects on ROMK function. However, it is unknown whether ROMK mutations exert any effects on CASR function and PTH physiology. Preliminary data from our center shows that PTH levels were specifically elevated in type II (where ROMK is mutated) and not in type IV (where another gene, Barttin is defective) BS, without a common explanation. We assume that the mutation in ROMK may cause a dysregulation of PTH secretion via possible interaction with CASR.

The purpose of this study is: to investigate the PT-gland function and regulation in BS.

Methods: Patients with BS type II and IV and normal controls will undergo a standard protocol of controlled ionic hypo- and hypercalcemia, during which PTH secretion, phosphate balance and calcium excretion will be followed. Calcium Vs PTH response curves will be generated and compared.

Expected impact and benefit: the results of this study will help understand the mechanisms of PTH regulation beyond CASR.


Condition or disease
Hypocalcemia Hypercalcemia

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Case-control Study of the PTH Homeostasis in Adolescents and Young Adults With Bartter Syndrome
Study Start Date : January 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Type II BS
Adolescents and young adults with type II Bartter syndrome
Type IV BS
Adolescents and adults with type IV Bartter syndrome
Controls
Age and sex- matched controls



Biospecimen Retention:   Samples Without DNA
Serum and urine will be later analyzed for FGF-23 and other key molecules in PTH homeostasis.


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Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescent and young adult patients with Bartter syndrome and age- and sex- matched controls.
Criteria

Inclusion Criteria:

  • Bartter syndrome
  • Normal Vitamin D status

Exclusion Criteria:

  • Age < 14 yrs

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): NCT01021280


Locations
Israel
Soroka University medical Center Not yet recruiting
Beer Sheva, Israel, 84101
Contact: Daniel Landau, MD    972-8-6400546    ldaniel@bgu.ac.il   
Contact: Ruth Schreiber, MD    972-8-6400546    ruthalon@rogers.com   
Principal Investigator: Daniel Landau, MD         
Sub-Investigator: Ruth Schreiber, MD         
Sponsors and Collaborators
Soroka University Medical Center
Ben-Gurion University of the Negev

Responsible Party: Daniel Landau MD, Head, Pediatrics Department A and Pediatric Nephrology Service, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01021280     History of Changes
Other Study ID Numbers: Sor492809ctil
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Daniel Landau MD, Soroka University Medical Center:
Bartter syndrome,
parathyroid hormone,
calcium sensing receptor,
ROMK channel
Barttin gene
PTH response to hypo- and hypercalcemia

Additional relevant MeSH terms:
Bartter Syndrome
Hypocalcemia
Hypercalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases