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Completed

NCT Number: NCT03159741

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

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inhibitor + GLP-2

Other

Inhibitor and GLP-2 are used as study tools.

Placebo + GLP-2

Other

Placebo and GLP-2 are used as study tools.

Placebo + GIP

Other

Placebo and GIP are used as study tools.

Placebo + Saline

Other

Placebo

Primary outcomes

  1. C-terminal telopeptide (CTX)

    Time frame: -30 to 240 min.

    Marker of bone resorption

Secondary outcomes

  1. N-terminal propeptide of type 1 procollagen (P1NP)

    Time frame: -30 to 240 min.

    Marker of bone formation

  2. Osteocalcin (OC)

    Time frame: -30 to 240 min.

    Bone marker

  3. Parathyroid hormone (PTH)

    Time frame: -30 to 240 min.

    Bone marker

  4. Osteoprotegerin (OPG)

    Time frame: -30 to 240 min.

    Bone marker

  5. Glucose-dependent insulinotropic polypeptide (GIP)

    Time frame: -30 to 240 min.

    GIP total and intact

  6. Glukagon-like peptide-1 (GLP-1) and glukagon-like peptide-2 (GLP-2)

    Time frame: -30 to 240 min.

  7. Glukagon and pancreatic polypeptide (PP)

    Time frame: -30 to 240 min.

  8. Glucose

    Time frame: -30 to 240 min.

  9. Insulin/c-pep.

    Time frame: -30 to 240 min.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 19, 2017
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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