NCT03159741

Brief Summary

Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit the bone resorption. However, the mechanism is unknown. In the present study we will investigate the mechanism of action using a receptor specific inhibitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2017

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

May 16, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

May 17, 2017

Last Update Submit

January 15, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • C-terminal telopeptide (CTX)

    Marker of bone resorption

    -30 to 240 min.

Secondary Outcomes (9)

  • N-terminal propeptide of type 1 procollagen (P1NP)

    -30 to 240 min.

  • Osteocalcin (OC)

    -30 to 240 min.

  • Parathyroid hormone (PTH)

    -30 to 240 min.

  • Osteoprotegerin (OPG)

    -30 to 240 min.

  • Glucose-dependent insulinotropic polypeptide (GIP)

    -30 to 240 min.

  • +4 more secondary outcomes

Study Arms (4)

Inhibitor + GLP-2

EXPERIMENTAL
Other: Inhibitor + GLP-2

Placebo + GLP-2

EXPERIMENTAL
Other: Placebo + GLP-2

Placebo + GIP

ACTIVE COMPARATOR
Other: Placebo + GIP

Placebo + Saline

PLACEBO COMPARATOR
Other: Placebo + Saline

Interventions

Inhibitor + GLP-2OTHER

Inhibitor and GLP-2 are used as study tools.

Inhibitor + GLP-2
Placebo + GLP-2OTHER

Placebo and GLP-2 are used as study tools.

Placebo + GLP-2
Placebo + GIPOTHER

Placebo and GIP are used as study tools.

Placebo + GIP
Placebo + SalineOTHER

Placebo

Placebo + Saline

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, 20 to 40 years old, caucasian, BMI 18,5 to 24,9 kg/m2

You may not qualify if:

  • Chronic disease, smoking, medication, weight change more than 3 kg whitin the last 3 months, overweight surgery, intestinal surgery, Hgb\<8,0 mmol/L, decreased renal function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Skov-Jeppesen K, Svane MS, Martinussen C, Gabe MBN, Gasbjerg LS, Veedfald S, Bojsen-Moller KN, Madsbad S, Holst JJ, Rosenkilde MM, Hartmann B. GLP-2 and GIP exert separate effects on bone turnover: A randomized, placebo-controlled, crossover study in healthy young men. Bone. 2019 Aug;125:178-185. doi: 10.1016/j.bone.2019.05.014. Epub 2019 May 15.

    PMID: 31100534DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mette Rosenkilde, MD

    University of Copenhagen

    STUDY DIRECTOR

  • Sten Madsbad, MD

    Hvidovre University Hospital

    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
Investigator

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

May 16, 2017

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

DK(1)