Investigation of GLP-2 Mechanism of Action (GA-8)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

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:

  • Healthy, 20 to 40 years old, caucasian, BMI 18,5 to 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
Experimental: Inhibitor + GLP-2
Other: Inhibitor + GLP-2
Inhibitor and GLP-2 are used as study tools.
Experimental: Placebo + GLP-2
Other: Placebo + GLP-2
Placebo and GLP-2 are used as study tools.
Active Comparator: Placebo + GIP
Other: Placebo + GIP
Placebo and GIP are used as study tools.
Placebo Comparator: Placebo + Saline
Other: Placebo + Saline
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-terminal telopeptide (CTX)
Time Frame: -30 to 240 min.
Marker of bone resorption
-30 to 240 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N-terminal propeptide of type 1 procollagen (P1NP)
Time Frame: -30 to 240 min.
Marker of bone formation
-30 to 240 min.
Osteocalcin (OC)
Time Frame: -30 to 240 min.
Bone marker
-30 to 240 min.
Parathyroid hormone (PTH)
Time Frame: -30 to 240 min.
Bone marker
-30 to 240 min.
Osteoprotegerin (OPG)
Time Frame: -30 to 240 min.
Bone marker
-30 to 240 min.
Glucose-dependent insulinotropic polypeptide (GIP)
Time Frame: -30 to 240 min.
GIP total and intact
-30 to 240 min.
Glukagon-like peptide-1 (GLP-1) and glukagon-like peptide-2 (GLP-2)
Time Frame: -30 to 240 min.
-30 to 240 min.
Glukagon and pancreatic polypeptide (PP)
Time Frame: -30 to 240 min.
-30 to 240 min.
Glucose
Time Frame: -30 to 240 min.
-30 to 240 min.
Insulin/c-pep.
Time Frame: -30 to 240 min.
-30 to 240 min.

Collaborators and Investigators

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

Sponsor

University of Copenhagen

Collaborators

Hvidovre University Hospital

Investigators

  • Study Director: Sten Madsbad, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 16, 2017

Primary Completion (Actual)

September 29, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

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

  • GA-8-2017

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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