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Completed

NCT Number: NCT03728959

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

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.

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Key information

Conditions

Hypoparathyroidism Bone Diseases Bone Resorption Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Genetic Diseases, Inborn Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Xanthomatosis Xanthomatosis, Cerebrotendinous

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Liquid meal (Nutridrink)

Other

Liquid meal ingested over 1 minute.

GIP

Other

Subcutaneous injected GIP

GLP-2

Other

Subcutaneous injected GLP-2

placebo (saline)

Other

Subcutaneous injected Placebo (saline)

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

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

Acronym: KS-4-HypoPT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2018
Registry last updated
Dec 12, 2019

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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