NCT03574064

Brief Summary

We will investigate effects of gut hormones on bone remodeling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2018

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

June 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

June 7, 2018

Last Update Submit

January 14, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • C-terminal telopeptide (CTX). At all time points and AUC(0-240 min).

    CTX is a marker of bone resorption. Measured in serum.

    -10 minutes to 600 minutes

  • N-terminal propeptide of type 1 procollagen (P1NP). At all time points and AUC(0-240 min).

    P1NP is a marker of bone formation. Measured in serum.

    -10 minutes to 600 minutes

Secondary Outcomes (11)

  • PTH

    -10 minutes to 600 minutes

  • Sclerostin

    -10 minutes to 600 minutes

  • Calcium

    -10 minutes to 600 minutes

  • Glucose

    -10 minutes to 600 minutes

  • Glucose-dependent insulinotropic polypeptide (GIP)

    -10 minutes to 600 minutes

  • +6 more secondary outcomes

Other Outcomes (2)

  • Blood pressure

    -10 minutes to 60 minutes

  • Heart rate

    -10 minutes to 60 minutes

Study Arms (4)

GLP-2

EXPERIMENTAL

Glucagon-Like Peptide-2 (GLP-2)

Other: Glucagon-Like Peptide-2 (GLP-2)

GIP

EXPERIMENTAL

Glucose-dependent Insulinotropic polypeptide (GIP)

Other: Glucose-dependent insulinotropic polypeptide (GIP)

GLP-2+GIP

EXPERIMENTAL

GLP-2+GIP

Other: GLP-2+GIP

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Glucagon-Like Peptide-2 (GLP-2)OTHER

Glucagon-Like Peptide-2 (GLP-2) injection.

GLP-2
Glucose-dependent insulinotropic polypeptide (GIP)OTHER

Glucose-dependent insulinotropic polypeptide (GIP) injection.

GIP
GLP-2+GIPOTHER

GLP-2+GIP injection.

GLP-2+GIP
PlaceboOTHER

Placebo injection.

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women Age above 50 years Postmenopausal Caucasian BMI 18.5 to 28.0 kg/m2.

You may not qualify if:

  • Smoking Medication believed to influence study outcome Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb\<7,0 mmol/L Decreased renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Interventions

Incretins

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2018

First Posted

June 29, 2018

Study Start

June 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

DK(1)