NCT05181150

Brief Summary

Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 18, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

December 18, 2021

Last Update Submit

May 9, 2023

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuryGIPGLP-2CTXP1NPBone resorptionBone formationBone turnoverBone remodeling

Outcome Measures

Primary Outcomes (1)

  • CTX

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

    -10 to 240 minutes

Secondary Outcomes (11)

  • P1NP

    -10 to 240 minutes

  • PTH

    -10 to 240 minutes

  • Sclerostin

    -10 to 240 minutes

  • Glucose

    -10 to 240 minutes

  • Insulin

    -10 to 240 minutes

  • +6 more secondary outcomes

Study Arms (5)

Meal test

EXPERIMENTAL
Other: Meal test

GIP, Glucose-dependent insulinotropic polypeptide

EXPERIMENTAL
Other: GIP

GLP-2, Glucagon-like-peptide-2

EXPERIMENTAL
Other: GLP-2

GIP + GLP-2

EXPERIMENTAL
Other: GIP + GLP-2

Placebo (saline)

PLACEBO COMPARATOR
Other: Placebo

Interventions

Meal testOTHER

Ingestion of an oral liquid meal (nutridrink), 200 mL.

Also known as: Nutridrink
Meal test
GIPOTHER

Subcutaneous GIP injection.

GIP, Glucose-dependent insulinotropic polypeptide
GLP-2OTHER

Subcutaneous GLP-2 injection.

GLP-2, Glucagon-like-peptide-2
GIP + GLP-2OTHER

Subcutaneous GIP + GLP-2 injection.

GIP + GLP-2
PlaceboOTHER

Subcutaneous saline injection.

Placebo (saline)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury resulting in the need of a wheelchair
  • BMI: 16-32 kg/m2
  • Intact spinal cord
  • Matched on gender, age and BMI to the group with spinal cord injury

You may not qualify if:

  • Treatment with antidiabetics
  • Treatment with anti-resorptive agents
  • Gastrointestinal disease
  • Smoking
  • Long term steroid treatment
  • Weight change more than 3 kg within the last 3 months.
  • Overweight or intestinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesBone Resorption

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Mette M Rosenkilde, Prof., MD

    University of Copenhagen

    STUDY DIRECTOR

Central Study Contacts

Charlotte B Christiansen, PhD

CONTACT

+45 22459802cbchristiansen@sund.ku.dk

Kirsa Skov-Jeppesen, PhD

CONTACT

+45 26818619kirsa@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 18, 2021

First Posted

January 6, 2022

Study Start

November 16, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)