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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03573934
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Kirsa Skov-Jeppesen, University of Copenhagen

Study Description
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Brief Summary:
Effects of GLP-2 and GIP on bone remodeling in healthy young men.

Condition or disease Intervention/treatment Phase
Healthy Other: GLP-2 Other: GIP Other: GLP-2+GIP Other: Placebo Not Applicable

Detailed Description:
We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Investigation of GLP-2 Mechanism of Action (KS-2)
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: GLP-2
Glucagon-Like Peptide-2 (GLP-2) injection
 Other: GLP-2
GLP-2
Experimental: GIP
Glucose-dependent Insulinotropic polypeptide (GIP) injection
 Other: GIP
GIP
Experimental: GLP-2+GIP
GLP-2+GIP injection
 Other: GLP-2+GIP
GLP-2+GIP
Placebo Comparator: Placebo
Placebo injection
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573934


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
University of Copenhagen
Hvidovre University Hospital
More Information
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Responsible Party: Kirsa Skov-Jeppesen, Principal Investigator., University of Copenhagen
ClinicalTrials.gov Identifier: NCT03573934    
Other Study ID Numbers: UCHP-KS-2
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins