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Completed

NCT Number: NCT03573934

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

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

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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

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

GLP-2

Other

GLP-2

GIP

Other

GIP

GLP-2+GIP

Other

GLP-2+GIP

Placebo

Other

Placebo

Primary outcomes

  1. Bone resorption

    Time frame: From -10 minutes to 240 minutes.

    C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum.

  2. Bone formation

    Time frame: From -10 minutes to 240 minutes.

    P1NP is a marker of bone formation. Measured in serum.

Secondary outcomes

  1. Parathyroid hormone

    Time frame: From -10 minutes to 240 minutes.

    PTH is a bone marker

  2. Calcium

    Time frame: From -10 minutes to 240 minutes.

    Measured in serum.

  3. GIP

    Time frame: From -10 minutes to 240 minutes.

    Intact and total GIP.

  4. GLP-2

    Time frame: From -10 minutes to 240 minutes.

    Intact GLP-2

  5. Glucose

    Time frame: From -10 minutes to 240 minutes.

    Measured in serum.

  6. Insulin

    Time frame: From -10 minutes to 240 minutes.

    Measured in serum.

  7. C-peptide

    Time frame: From -10 minutes to 240 minutes.

    Measured in serum.

  8. Sclerostin

    Time frame: From -10 minutes to 240 minutes.

    Bone marker.

Other outcomes

  1. Heart rate

    Time frame: From -10 minutes to 240 minutes.

    Before blood sampling

  2. Blood pressure

    Time frame: From -10 minutes to 240 minutes.

    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 (KS-2)

Acronym: KS-2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2018
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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