Effects of Gut Peptides on Bone Remodeling (KS-3)

January 14, 2021 updated by: Kirsa Skov-Jeppesen, University of Copenhagen

Investigation of GLP-2 Mechanism of Action

We will investigate effects of gut hormones on bone remodeling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo injection.
Experimental: GLP-2
Glucagon-Like Peptide-2 (GLP-2)
Other: Glucagon-Like Peptide-2 (GLP-2)
Glucagon-Like Peptide-2 (GLP-2) injection.
Experimental: GIP
Glucose-dependent Insulinotropic polypeptide (GIP)
Other: Glucose-dependent insulinotropic polypeptide (GIP)
Glucose-dependent insulinotropic polypeptide (GIP) injection.
Experimental: GLP-2+GIP
Other: GLP-2+GIP
GLP-2+GIP injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-terminal telopeptide (CTX). At all time points and AUC(0-240 min).
Time Frame: -10 minutes to 600 minutes
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).
Time Frame: -10 minutes to 600 minutes
P1NP is a marker of bone formation. Measured in serum.
-10 minutes to 600 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTH
Time Frame: -10 minutes to 600 minutes
Bone marker. Measured in serum.
-10 minutes to 600 minutes
Sclerostin
Time Frame: -10 minutes to 600 minutes
Bone marker.
-10 minutes to 600 minutes
Calcium
Time Frame: -10 minutes to 600 minutes
Measured in serum within 5 days.
-10 minutes to 600 minutes
Glucose
Time Frame: -10 minutes to 600 minutes
Measured in serum.
-10 minutes to 600 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Time Frame: -10 minutes to 600 minutes
Total and intact GIP. Measured in plasma.
-10 minutes to 600 minutes
Insulin
Time Frame: -10 minutes to 600 minutes
Measured in serum.
-10 minutes to 600 minutes
C-peptide
Time Frame: -10 minutes to 600 minutes
Measured in serum.
-10 minutes to 600 minutes
Glukagon-like peptide-1 (GLP-1)
Time Frame: -10 minutes to 600 minutes
Measured in plasma.
-10 minutes to 600 minutes
Glucagon
Time Frame: -10 minutes to 600 minutes
Measured in plasma.
-10 minutes to 600 minutes
Glukagon-like peptide-2 (GLP-2)
Time Frame: -10 minutes to 600 minutes
Intact GLP-2. Measured in plasma.
-10 minutes to 600 minutes
PP
Time Frame: -10 minutes to 600 minutes
Measured in plasma.
-10 minutes to 600 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: -10 minutes to 60 minutes
Measured before blood sampling.
-10 minutes to 60 minutes
Heart rate
Time Frame: -10 minutes to 60 minutes
Measured before blood sampling.
-10 minutes to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCPH-KS-3-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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