NCT03573934

Brief Summary

Effects of GLP-2 and GIP on bone remodeling in healthy young men.

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 Sep 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

September 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
3 months 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
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

June 7, 2018

Last Update Submit

January 15, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Bone resorption

    C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum.

    From -10 minutes to 240 minutes.

  • Bone formation

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

    From -10 minutes to 240 minutes.

Secondary Outcomes (8)

  • Parathyroid hormone

    From -10 minutes to 240 minutes.

  • Calcium

    From -10 minutes to 240 minutes.

  • GIP

    From -10 minutes to 240 minutes.

  • GLP-2

    From -10 minutes to 240 minutes.

  • Glucose

    From -10 minutes to 240 minutes.

  • +3 more secondary outcomes

Other Outcomes (2)

  • Heart rate

    From -10 minutes to 240 minutes.

  • Blood pressure

    From -10 minutes to 240 minutes.

Study Arms (4)

GLP-2

EXPERIMENTAL

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

Other: GLP-2

GIP

EXPERIMENTAL

Glucose-dependent Insulinotropic polypeptide (GIP) injection

Other: GIP

GLP-2+GIP

EXPERIMENTAL

GLP-2+GIP injection

Other: GLP-2+GIP

Placebo

PLACEBO COMPARATOR

Placebo injection

Other: Placebo

Interventions

GLP-2OTHER

GLP-2

GLP-2
GIPOTHER

GIP

GIP
GLP-2+GIPOTHER

GLP-2+GIP

GLP-2+GIP
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Age between 20 and 40 years old Caucasian Healthy BMI between 18.5 and 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

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.

Study Record Dates

First Submitted

June 7, 2018

First Posted

June 29, 2018

Study Start

September 15, 2017

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

DK(1)