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Clinical Trials/NCT03574064
NCT03574064CompletedNot Applicable

Investigation of GLP-2 Mechanism of Action

University of Copenhagen2 sites in 1 country10 target enrollmentStarted: June 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
N-terminal propeptide of type 1 procollagen (P1NP). At all time points and AUC(0-240 min).

Study Overview

Brief Summary

We will investigate effects of gut hormones on bone remodeling.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Calcium(-10 minutes to 600 minutes)
  • Insulin(-10 minutes to 600 minutes)
  • Glukagon-like peptide-2 (GLP-2)(-10 minutes to 600 minutes)
  • C-peptide(-10 minutes to 600 minutes)
  • PTH(-10 minutes to 600 minutes)
  • Sclerostin(-10 minutes to 600 minutes)
  • PP(-10 minutes to 600 minutes)
  • Glucose(-10 minutes to 600 minutes)
  • Glucose-dependent insulinotropic polypeptide (GIP)(-10 minutes to 600 minutes)
  • Glukagon-like peptide-1 (GLP-1)(-10 minutes to 600 minutes)
  • Glucagon(-10 minutes to 600 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kirsa Skov-Jeppesen

Principal Investigator

University of Copenhagen

Study Sites (2)

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