Gut Hormones and Bone Remodeling in Humans (KS-2) (KS-2)

January 15, 2020 updated by: Kirsa Skov-Jeppesen, University of Copenhagen

Investigation of GLP-2 Mechanism of Action (KS-2)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Age between 20 and 40 years old Caucasian Healthy BMI between 18.5 and 24.9 kg/m2.

Exclusion Criteria:

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.

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: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone resorption
Time Frame: From -10 minutes to 240 minutes.
C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum.
From -10 minutes to 240 minutes.
Bone formation
Time Frame: From -10 minutes to 240 minutes.
P1NP is a marker of bone formation. Measured in serum.
From -10 minutes to 240 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parathyroid hormone
Time Frame: From -10 minutes to 240 minutes.
PTH is a bone marker
From -10 minutes to 240 minutes.
Calcium
Time Frame: From -10 minutes to 240 minutes.
Measured in serum.
From -10 minutes to 240 minutes.
GIP
Time Frame: From -10 minutes to 240 minutes.
Intact and total GIP.
From -10 minutes to 240 minutes.
GLP-2
Time Frame: From -10 minutes to 240 minutes.
Intact GLP-2
From -10 minutes to 240 minutes.
Glucose
Time Frame: From -10 minutes to 240 minutes.
Measured in serum.
From -10 minutes to 240 minutes.
Insulin
Time Frame: From -10 minutes to 240 minutes.
Measured in serum.
From -10 minutes to 240 minutes.
C-peptide
Time Frame: From -10 minutes to 240 minutes.
Measured in serum.
From -10 minutes to 240 minutes.
Sclerostin
Time Frame: From -10 minutes to 240 minutes.
Bone marker.
From -10 minutes to 240 minutes.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: From -10 minutes to 240 minutes.
Before blood sampling
From -10 minutes to 240 minutes.
Blood pressure
Time Frame: From -10 minutes to 240 minutes.
Before blood sampling
From -10 minutes to 240 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)

September 15, 2017

Primary Completion (Actual)

March 15, 2018

Study Completion (Actual)

March 15, 2018

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 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCHP-KS-2

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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