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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Hypoparathyroidism

Intervention / Treatment
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* Other: Liquid meal (Nutridrink)
* Other: GIP
* Other: GLP-2
* Other: Placebo (saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid meal (Nutridrink)<br>Liquid meal (Nutridrink) | Other: Liquid meal (Nutridrink)<br>* Liquid meal ingested over 1 minute.<br>|
| Experimental: GIP<br>Glucose-dependent insulinotropic polypeptide | Other: GIP<br>* Subcutaneous injected GIP<br>|
| Experimental: GLP-2<br>Glucagon-like peptide-2 | Other: GLP-2<br>* Subcutaneous injected GLP-2<br>|
| Experimental: Placebo (saline)<br>Placebo (saline) | Other: Placebo (saline)<br>* Subcutaneous injected Placebo (saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of C-terminal telopeptide (CTX) | Marker of bone resorption, measured in serum | -10 to 240 minutes | 
| N-terminal propeptide of type 1 procollagen (P1NP) | Marker of bone formation, concentration measured in serum | -10 to 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH | PTH concentration measured in serum | -10 to 240 minutes | 
| Glucose-dependent insulinotropic polypeptide (GIP) | Gut hormone, concentration measured in plasma | -10 to 240 minutes | 
| Glucagon-like peptide-2 (GLP-2) | Gut hormone, concentration measured in plasma | -10 to 240 minutes | 
| Glucagon-like peptide-1 (GLP-1) | Gut hormone, concentration measured in plasma | -10 to 240 minutes | 
| Glucose | Glucose concentration measured in serum | -10 to 240 minutes | 
| Insulin | Insulin concentration measured in serum | -10 to 240 minutes | 
| C-peptide | C-peptide concentration measured in serum | -10 to 240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)