NCT03728959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

October 31, 2018

Last Update Submit

December 11, 2019

Conditions

Hypoparathyroidism

Keywords

hypoparathyroidismGlucose-dependent insulinotropic polypeptide (GIP)Glucagon-like peptide-2 (GLP-2)Bone remodelingBone resorptionBone formationC-terminal telopeptide (CTX)N-terminal propeptide of type 1 procollagen (P1NP)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • PTH

    -10 to 240 minutes

  • Glucose-dependent insulinotropic polypeptide (GIP)

    -10 to 240 minutes

  • Glucagon-like peptide-2 (GLP-2)

    -10 to 240 minutes

  • Glucagon-like peptide-1 (GLP-1)

    -10 to 240 minutes

  • Glucose

    -10 to 240 minutes

  • +2 more secondary outcomes

Other Outcomes (2)

  • Blood pressure

    -10 to 240 minutes

  • Heart rate

    -10 to 240 minutes

Study Arms (4)

Liquid meal (Nutridrink)

EXPERIMENTAL

Liquid meal (Nutridrink)

Other: Liquid meal (Nutridrink)

GIP

EXPERIMENTAL

Glucose-dependent insulinotropic polypeptide

Other: GIP

GLP-2

EXPERIMENTAL

Glucagon-like peptide-2

Other: GLP-2

Placebo (saline)

EXPERIMENTAL

Placebo (saline)

Other: Placebo (saline)

Interventions

Liquid meal (Nutridrink)OTHER

Liquid meal ingested over 1 minute.

Liquid meal (Nutridrink)
GIPOTHER

Subcutaneous injected GIP

GIP
GLP-2OTHER

Subcutaneous injected GLP-2

GLP-2
Placebo (saline)OTHER

Subcutaneous injected Placebo (saline)

Placebo (saline)

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 76
  • Hypoparathyroidism

You may not qualify if:

  • Diabetes
  • Disease in the gastrointestinal tract
  • Antiosteoporotic drug
  • Long term steroid treatment (within the last 12 months)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

HypoparathyroidismBone ResorptionXanthomatosis, Cerebrotendinous

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesBone DiseasesMusculoskeletal DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesXanthomatosis

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mette Rosenkilde, MD

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator. Cand.pharm., ph.d. student

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 2, 2018

Study Start

September 12, 2018

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

DK(1)