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NCT03728959 Clinical Trial

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

Hypoparathyroidism Clinical Trial

— KS-4-HypoPT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03728959
Other study ID # KS-4-HypoPT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2018
Est. completion date April 12, 2019

Study information
Verified date December 2019
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date April 12, 2019
Est. primary completion date April 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Liquid meal (Nutridrink)
Liquid meal ingested over 1 minute.
• GIP
Subcutaneous injected GIP
• GLP-2
Subcutaneous injected GLP-2
• Placebo (saline)
Subcutaneous injected Placebo (saline)

Locations
Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (2)
Lead Sponsor Collaborator
University of Copenhagen Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Blood pressure Blood pressure (systolic and diastolic) measured before blood sampling -10 to 240 minutes
Other Heart rate Heart rate measured before blood sampling -10 to 240 minutes
Primary Serum concentration of C-terminal telopeptide (CTX) Marker of bone resorption, measured in serum -10 to 240 minutes
Primary N-terminal propeptide of type 1 procollagen (P1NP) Marker of bone formation, concentration measured in serum -10 to 240 minutes
Secondary PTH PTH concentration measured in serum -10 to 240 minutes
Secondary Glucose-dependent insulinotropic polypeptide (GIP) Gut hormone, concentration measured in plasma -10 to 240 minutes
Secondary Glucagon-like peptide-2 (GLP-2) Gut hormone, concentration measured in plasma -10 to 240 minutes
Secondary Glucagon-like peptide-1 (GLP-1) Gut hormone, concentration measured in plasma -10 to 240 minutes
Secondary Glucose Glucose concentration measured in serum -10 to 240 minutes
Secondary Insulin Insulin concentration measured in serum -10 to 240 minutes
Secondary C-peptide C-peptide concentration measured in serum -10 to 240 minutes
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