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

NCT ID: NCT03159741

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2017-09-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inhibitor + GLP-2

Group Type EXPERIMENTAL

Inhibitor + GLP-2

Intervention Type OTHER

Inhibitor and GLP-2 are used as study tools.

Placebo + GLP-2

Group Type EXPERIMENTAL

Placebo + GLP-2

Intervention Type OTHER

Placebo and GLP-2 are used as study tools.

Placebo + GIP

Group Type ACTIVE_COMPARATOR

Placebo + GIP

Intervention Type OTHER

Placebo and GIP are used as study tools.

Placebo + Saline

Group Type PLACEBO_COMPARATOR

Placebo + Saline

Intervention Type OTHER

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inhibitor + GLP-2

Inhibitor and GLP-2 are used as study tools.

Intervention Type OTHER

Placebo + GLP-2

Placebo and GLP-2 are used as study tools.

Intervention Type OTHER

Placebo + GIP

Placebo and GIP are used as study tools.

Intervention Type OTHER

Placebo + Saline

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kirsa Skov-Jeppesen

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mette Rosenkilde, MD

Role: STUDY_DIRECTOR

University of Copenhagen

Sten Madsbad, MD

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Skov-Jeppesen K, Svane MS, Martinussen C, Gabe MBN, Gasbjerg LS, Veedfald S, Bojsen-Moller KN, Madsbad S, Holst JJ, Rosenkilde MM, Hartmann B. GLP-2 and GIP exert separate effects on bone turnover: A randomized, placebo-controlled, crossover study in healthy young men. Bone. 2019 Aug;125:178-185. doi: 10.1016/j.bone.2019.05.014. Epub 2019 May 15.

Reference Type DERIVED
PMID: 31100534 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GA-8-2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Location of GLP-1 Release
NCT02036710 COMPLETED