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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03728959
Acronym
KS-4-HypoPT
Enrollment
7
Registered
2018-11-02
Start date
2018-09-12
Completion date
2019-04-12
Last updated
2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoparathyroidism

Keywords

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)

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.

Interventions

OTHERLiquid meal (Nutridrink)

Liquid meal ingested over 1 minute.

OTHERGIP

Subcutaneous injected GIP

OTHERGLP-2

Subcutaneous injected GLP-2

OTHERPlacebo (saline)

Subcutaneous injected Placebo (saline)

Sponsors

Hvidovre University Hospital
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum concentration of C-terminal telopeptide (CTX)-10 to 240 minutesMarker of bone resorption, measured in serum
N-terminal propeptide of type 1 procollagen (P1NP)-10 to 240 minutesMarker of bone formation, concentration measured in serum

Secondary

MeasureTime frameDescription
C-peptide-10 to 240 minutesC-peptide concentration measured in serum
Glucose-10 to 240 minutesGlucose concentration measured in serum
Insulin-10 to 240 minutesInsulin concentration measured in serum
PTH-10 to 240 minutesPTH concentration measured in serum
Glucose-dependent insulinotropic polypeptide (GIP)-10 to 240 minutesGut hormone, concentration measured in plasma
Glucagon-like peptide-2 (GLP-2)-10 to 240 minutesGut hormone, concentration measured in plasma
Glucagon-like peptide-1 (GLP-1)-10 to 240 minutesGut hormone, concentration measured in plasma

Other

MeasureTime frameDescription
Heart rate-10 to 240 minutesHeart rate measured before blood sampling
Blood pressure-10 to 240 minutesBlood pressure (systolic and diastolic) measured before blood sampling

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026