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Extragonadal Effects of hCG on Calcium Homeostasis

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ClinicalTrials.gov Identifier: NCT03418896
Recruitment Status : Active, not recruiting
First Posted : February 1, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Blomberg Jensen, Rigshospitalet, Denmark

Brief Summary:
A pilot study showed that serum calcium levels and calcium homeostasis change in response to hCG stimulation test. Serum calcium level differed when comparing pretreatment values at baseline with serum levels 72 hours after hCG stimulation in men with gonadal insufficiency referred for this stimulation test. Now we want to investigate whether this change in calcium is due to renal loss or other mechanisms and how the classical regulators of calcium homeostasis respond to hCG in men with impaired gonadal function compared with men having normal gonadal function. Moreover, the observed change in serum calcium implies that hCG also changes Phosphate, PTH and calcitonin and this will be clarified with this study

Condition or disease Intervention/treatment Phase
Hypogonadism Calcium Disorder Renal Disease Drug: human chorionic gonadotropin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: simple one arm intervention study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Novel Extragonadal Effects of Human Chorion Gonadotropin (hCG) on Calcium Homeostasis
Actual Study Start Date : January 6, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: human chorion gonadotropin
Pregnyl, hCG, 5000 IU times one im.
Drug: human chorionic gonadotropin
a single injection of a standard dose




Primary Outcome Measures :
  1. Serum calcium [ Time Frame: 2,8,24, 72,120 hours ]
    changes albumin corrected calcium, ionized calcium, total calcium


Secondary Outcome Measures :
  1. urinary calcium and phosphate excretion [ Time Frame: 2,8,24, 72,120 hours ]
    calcium and phosphate clearance and fractional excretion

  2. serum Phosphate [ Time Frame: 2,8,24, 72,120 hours ]
    changes in serum phosphate


Other Outcome Measures:
  1. vitamin D metabolites [ Time Frame: 2,8,24, 72,120 hours ]
    25OHD, 1,25OH2D3, 24,25OH2D3

  2. calcitonin [ Time Frame: 2,8,24, 72,120 hours ]
    changes in serum calcitonin

  3. Cortisol [ Time Frame: 2,8,24, 72,120 hours ]
    Changes in serum cortisol

  4. adrenal steroidogenesis [ Time Frame: 2,8,24, 72,120 hours ]
    all measurable steroids part of steroidogenesis by LCMS

  5. sex steroids [ Time Frame: 2,8,24, 72,120 hours ]
    total and free calculated levels of sex steroids including T/LH

  6. reproductive hormones [ Time Frame: 2,8,24, 72,120 hours ]
    AMH, Inhibin B, FSH, including InhB/FSH

  7. change in adipocyte function [ Time Frame: 2,8,24, 72,120 hours ]
    biomarkers in serum of adipocyte function, browning, differentiation, insulin, glucose, HB1AC etc

  8. LHCGR [ Time Frame: 2,8,24, 72,120 hours ]
    serum LHCGR may change

  9. regulators of calcium homeostasis [ Time Frame: 2,8,24, 72,120 hours ]
    serum calcitonin, FGF23, interferons, prostaglandins

  10. Kidney function [ Time Frame: 2,8,24, 72,120 hours ]
    changes in GFR, creatinine, Urea, pH, HCO3

  11. Electrocardiogram [ Time Frame: 2,8,24,72,120 hours ]
    changes in QT, corrected QY or QRS

  12. adipocyte function [ Time Frame: 2,8,24,72,120 hours ]
    changes in serum lipid or cholesterol or adipocyte function markers

  13. liver function [ Time Frame: 2,8,24,72,120 hours ]
    changes in albumin and hepatic binding proteins

  14. bone function [ Time Frame: 2,8,24,72,120 hours ]
    changes in bone markers such as CTX, osteocalcin and endocrine bone factors RANKL, OPG, RANK, sclerostin

  15. serum PTH [ Time Frame: 2,8,24,72,120 hours ]
    changes in serum PTH

  16. urinary excretion of steroids [ Time Frame: 2,8,24,72,120 hours ]
    cortisol and sex steroids

  17. Cardiovascular biomarkers [ Time Frame: 2,8,24,72,120 hours ]
    ANP and BNP

  18. glucose homeostasis [ Time Frame: 2,8,24,72,120 hours ]
    insulin, glucose, c-peptid, HB1AC, HOMA, Quicki

  19. incretin hormones [ Time Frame: 2,8,24,72,120 hours ]
    glucagon, and GLP-1

  20. electrolytes [ Time Frame: 2,8,24,72,120 hours ]
    Magnesium, potassium, sodium



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   males
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: to be either

  • a man with normal reproductive function
  • or a man with known impaired gonadal function
  • more than 18 years of age and less than 80 years of age

Exclusion Criteria:

  • presence of current serious diseases
  • or presence of disease requiring constant and lifelong treatment with chemotherapy or other toxic drugs
  • Men treated with testosterone who do not stop their treatment while being part of the study,

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): NCT03418896


Locations
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Denmark
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Martin Blomberg Jensen
Investigators
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Study Chair: Martin blomberg Jensen Rigshospitalet, Denmark

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Responsible Party: Martin Blomberg Jensen, Group leader, MD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03418896     History of Changes
Other Study ID Numbers: 2016-003546-84
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Normally we share the data through an official danish Databank handling all these things

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Reproductive Control Agents