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OpenTrials
Completed

NCT Number: NCT03574064

Effects of Gut Peptides on Bone Remodeling

We will investigate effects of gut hormones on bone remodeling.

Completed

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Key information

Conditions

Healthy

Age range

50 year–80 year

Sex eligibility

Female

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

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

Treatment and study plan

Glucagon-Like Peptide-2 (GLP-2)

Other

Glucagon-Like Peptide-2 (GLP-2) injection.

Glucose-dependent Insulinotropic Polypeptide (GIP)

Other

Glucose-dependent insulinotropic polypeptide (GIP) injection.

GLP-2+GIP

Other

GLP-2+GIP injection.

Placebo

Other

Placebo injection.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. PTH

    Time frame: -10 minutes to 600 minutes

    Bone marker. Measured in serum.

  2. Sclerostin

    Time frame: -10 minutes to 600 minutes

    Bone marker.

  3. Calcium

    Time frame: -10 minutes to 600 minutes

    Measured in serum within 5 days.

  4. Glucose

    Time frame: -10 minutes to 600 minutes

    Measured in serum.

  5. Glucose-dependent insulinotropic polypeptide (GIP)

    Time frame: -10 minutes to 600 minutes

    Total and intact GIP. Measured in plasma.

  6. Insulin

    Time frame: -10 minutes to 600 minutes

    Measured in serum.

  7. C-peptide

    Time frame: -10 minutes to 600 minutes

    Measured in serum.

  8. Glukagon-like peptide-1 (GLP-1)

    Time frame: -10 minutes to 600 minutes

    Measured in plasma.

  9. Glucagon

    Time frame: -10 minutes to 600 minutes

    Measured in plasma.

  10. Glukagon-like peptide-2 (GLP-2)

    Time frame: -10 minutes to 600 minutes

    Intact GLP-2. Measured in plasma.

  11. PP

    Time frame: -10 minutes to 600 minutes

    Measured in plasma.

Other outcomes

  1. Blood pressure

    Time frame: -10 minutes to 60 minutes

    Measured before blood sampling.

  2. Heart rate

    Time frame: -10 minutes to 60 minutes

    Measured before blood sampling.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

Investigation of GLP-2 Mechanism of Action

Acronym: KS-3

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2018
Registry last updated
Jan 20, 2021

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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