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

Not Applicable

Completed

• Conditions: Hypoparathyroidism
• Interventions: Other: GIP; Other: Liquid meal (Nutridrink); Other: GLP-2; Other: Placebo (saline)

• Registration Number: NCT03728959
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-12
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Primary Completion: 2019-04-12
• Study Completion: 2019-04-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIP	GIP	Glucose-dependent insulinotropic polypeptide
Liquid meal (Nutridrink)	Liquid meal (Nutridrink)	Liquid meal (Nutridrink)
GLP-2	GLP-2	Glucagon-like peptide-2
Placebo (saline)	Placebo (saline)	Placebo (saline)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark