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CompletedNCT03867656Updated Nov 4, 2020

Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19

An interventional study of GLP-2 and GIP in Type 2 Diabetes Mellitus, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
Male
01

Study summary

Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 Diabetes Mellitus
  • Bone resorption
  • Bone formation
  • CTX
  • P1NP
  • GLP-2
  • GIP
  • Bone turnover
  • Bone remodeling
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • Age 25 to 70 years old.
  • Type 2 diabetes.
  • In Metformin or sulfonylureas

Exclusion criteria

Exclusion Criteria:

  • Treatment with other antidiabetics
  • Osteopososis or gastrointestinal disease
  • Smoking
  • Long term steroid treatment
  • Weight change more than 3 kg within the last 3 months.
  • Overweight or intestinal surgery
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    GLP-2

    Glucagon-like peptide 2

    Other: GLP-2

  • Experimental
    GIP

    Glucose-dependent insulinotropic polypeptide

    Other: GIP

  • Placebo comparator
    Placebo

    Saline

    Other: Placebo

Interventions

  • OtherGLP-2

    GLP-2 injection

  • OtherGIP

    GIP injection

  • OtherPlacebo

    Placebo injection

06

What researchers measure

Primary outcomes

  1. CTX

    Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.

    Time frame: -10 minutes to 240 minutes

  2. P1NP

    Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.

    Time frame: -10 minutes to 240 minutes

Secondary outcomes

  1. PTH

    PTH measured in serum

    Time frame: -10 minutes to 240 minutes

  2. Sclerostin

    Bone marker.

    Time frame: -10 min to 240 min.

  3. Glucose

    Measured in serum

    Time frame: -10 minutes to 240 minutes

  4. Insulin

    Measured in serum

    Time frame: -10 minutes to 240 minutes

  5. C-peptide

    Measured in serum

    Time frame: -10 minutes to 240 minutes

  6. GIP

    Glucose-dependent insulinotropic polypeptide measured in plasma.

    Time frame: -10 minutes to 240 minutes

  7. GLP-2

    Glucagon-like peptide 2 measured in plasma.

    Time frame: -10 minutes to 240 minutes

  8. Glucagon

    Glucagon measured in plasma

    Time frame: -10 minutes to 240 minutes

  9. Blood pressure

    Measured before blood sampling

    Time frame: -10 minutes to 240 minutes

  10. Heart rate

    Measured before blood sampling

    Time frame: -10 minutes to 240 minutes

07

Study locations

1 site
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03867656
Lead sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital
Responsible party
Kirsa Skov-Jeppesen (Principal Investigator, University of Copenhagen) — Principal investigator
First posted
Mar 8, 2019
Start date
Feb 26, 2019
Primary completion
Jun 26, 2020
Completion
Jun 26, 2020
Last update
Nov 4, 2020

Study contacts

Mette Rosenkilde, MD
study director · University of Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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