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Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism. (KS-4-HypoPT)

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ClinicalTrials.gov Identifier: NCT03728959
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Kirsa Skov-Jeppesen, University of Copenhagen

Brief Summary:

Hypoparathyroidism (hypoPT) is characterized by low levels of PTH.

In this study we will test the effects of a liquid meal on the bone remodeling in participants with hypoparathyroidism. Furthermore, we will test the effects of the gut hormones GIP and GLP-2.


Condition or disease Intervention/treatment Phase
Hypoparathyroidism Other: Liquid meal (Nutridrink) Other: GIP Other: GLP-2 Other: Placebo (saline) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism (KS-4-HypoPT).
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : April 12, 2019
Actual Study Completion Date : April 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Liquid meal (Nutridrink)
Liquid meal (Nutridrink)
Other: Liquid meal (Nutridrink)
Liquid meal ingested over 1 minute.

Experimental: GIP
Glucose-dependent insulinotropic polypeptide
Other: GIP
Subcutaneous injected GIP

Experimental: GLP-2
Glucagon-like peptide-2
Other: GLP-2
Subcutaneous injected GLP-2

Experimental: Placebo (saline)
Placebo (saline)
Other: Placebo (saline)
Subcutaneous injected Placebo (saline)




Primary Outcome Measures :
  1. Serum concentration of C-terminal telopeptide (CTX) [ Time Frame: -10 to 240 minutes ]
    Marker of bone resorption, measured in serum

  2. N-terminal propeptide of type 1 procollagen (P1NP) [ Time Frame: -10 to 240 minutes ]
    Marker of bone formation, concentration measured in serum


Secondary Outcome Measures :
  1. PTH [ Time Frame: -10 to 240 minutes ]
    PTH concentration measured in serum

  2. Glucose-dependent insulinotropic polypeptide (GIP) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, concentration measured in plasma

  3. Glucagon-like peptide-2 (GLP-2) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, concentration measured in plasma

  4. Glucagon-like peptide-1 (GLP-1) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, concentration measured in plasma

  5. Glucose [ Time Frame: -10 to 240 minutes ]
    Glucose concentration measured in serum

  6. Insulin [ Time Frame: -10 to 240 minutes ]
    Insulin concentration measured in serum

  7. C-peptide [ Time Frame: -10 to 240 minutes ]
    C-peptide concentration measured in serum


Other Outcome Measures:
  1. Blood pressure [ Time Frame: -10 to 240 minutes ]
    Blood pressure (systolic and diastolic) measured before blood sampling

  2. Heart rate [ Time Frame: -10 to 240 minutes ]
    Heart rate measured before blood sampling



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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 76
  • Hypoparathyroidism

Exclusion Criteria:

  • Diabetes
  • Disease in the gastrointestinal tract
  • Antiosteoporotic drug
  • Long term steroid treatment (within the last 12 months)
  • Pregnancy

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): NCT03728959


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
University of Copenhagen
Hvidovre University Hospital
Investigators
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Study Director: Mette Rosenkilde, MD University of Copenhagen
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Responsible Party: Kirsa Skov-Jeppesen, principal investigator. Cand.pharm., ph.d. student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03728959    
Other Study ID Numbers: KS-4-HypoPT
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirsa Skov-Jeppesen, University of Copenhagen:
hypoparathyroidism
Glucose-dependent insulinotropic polypeptide (GIP)
Glucagon-like peptide-2 (GLP-2)
Bone remodeling
Bone resorption
Bone formation
C-terminal telopeptide (CTX)
N-terminal propeptide of type 1 procollagen (P1NP)
Additional relevant MeSH terms:
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Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases