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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

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date December 12, 2019
Actual Study Start Date  ICMJE September 12, 2018
Actual Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Serum concentration of C-terminal telopeptide (CTX) [ Time Frame: -10 to 240 minutes ]
    Marker of bone resorption, measured in serum
  • N-terminal propeptide of type 1 procollagen (P1NP) [ Time Frame: -10 to 240 minutes ]
    Marker of bone formation, concentration measured in serum
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • C-terminal telopeptide (CTX) [ Time Frame: -10 to 240 minutes ]
    Marker of bone resorption, measured in serum
  • N-terminal propeptide of type 1 procollagen (P1NP) [ Time Frame: -10 to 240 minutes ]
    Marker of bone formation, measured in serum
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • PTH [ Time Frame: -10 to 240 minutes ]
    PTH concentration measured in serum
  • Glucose-dependent insulinotropic polypeptide (GIP) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, concentration measured in plasma
  • Glucagon-like peptide-2 (GLP-2) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, concentration measured in plasma
  • Glucagon-like peptide-1 (GLP-1) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, concentration measured in plasma
  • Glucose [ Time Frame: -10 to 240 minutes ]
    Glucose concentration measured in serum
  • Insulin [ Time Frame: -10 to 240 minutes ]
    Insulin concentration measured in serum
  • C-peptide [ Time Frame: -10 to 240 minutes ]
    C-peptide concentration measured in serum
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • PTH [ Time Frame: -10 to 240 minutes ]
    PTH measured in serum
  • Glucose-dependent insulinotropic polypeptide (GIP) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, measured in plasma
  • Glucagon-like peptide-2 (GLP-2) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, measured in plasma
  • Glucagon-like peptide-1 (GLP-1) [ Time Frame: -10 to 240 minutes ]
    Gut hormone, measured in plasma
  • Glucose [ Time Frame: -10 to 240 minutes ]
    Glucose measured in serum
  • Insulin [ Time Frame: -10 to 240 minutes ]
    Insulin measured in serum
  • C-peptide [ Time Frame: -10 to 240 minutes ]
    C-peptide measured in serum
Current Other Pre-specified Outcome Measures
 (submitted: November 5, 2018)
  • Blood pressure [ Time Frame: -10 to 240 minutes ]
    Blood pressure (systolic and diastolic) measured before blood sampling
  • Heart rate [ Time Frame: -10 to 240 minutes ]
    Heart rate measured before blood sampling
Original Other Pre-specified Outcome Measures
 (submitted: October 31, 2018)
  • Blood pressure [ Time Frame: -10 to 240 minutes ]
    Blood pressure measured before blood sampling
  • Heart rate [ Time Frame: -10 to 240 minutes ]
    Heart rate measured before blood sampling
 
Descriptive Information
Brief Title  ICMJE Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.
Official Title  ICMJE Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism (KS-4-HypoPT).
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Hypoparathyroidism
Intervention  ICMJE
  • Other: Liquid meal (Nutridrink)
    Liquid meal ingested over 1 minute.
  • Other: GIP
    Subcutaneous injected GIP
  • Other: GLP-2
    Subcutaneous injected GLP-2
  • Other: Placebo (saline)
    Subcutaneous injected Placebo (saline)
Study Arms  ICMJE
  • Experimental: Liquid meal (Nutridrink)
    Liquid meal (Nutridrink)
    Intervention: Other: Liquid meal (Nutridrink)
  • Experimental: GIP
    Glucose-dependent insulinotropic polypeptide
    Intervention: Other: GIP
  • Experimental: GLP-2
    Glucagon-like peptide-2
    Intervention: Other: GLP-2
  • Experimental: Placebo (saline)
    Placebo (saline)
    Intervention: Other: Placebo (saline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
8
Actual Study Completion Date  ICMJE April 12, 2019
Actual Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728959
Other Study ID Numbers  ICMJE KS-4-HypoPT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kirsa Skov-Jeppesen, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Hvidovre University Hospital
Investigators  ICMJE
Study Director: Mette Rosenkilde, MD University of Copenhagen
PRS Account University of Copenhagen
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP