Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05181150

Enrollment

Registered

2022-01-06

Start date

2021-11-16

Completion date

2024-11-30

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injury, GIP, GLP-2, CTX, P1NP, Bone resorption, Bone formation, Bone turnover, Bone remodeling

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.

Interventions

OTHERMeal test

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

OTHERGIP

Subcutaneous GIP injection.

OTHERGLP-2

Subcutaneous GLP-2 injection.

OTHERGIP + GLP-2

Subcutaneous GIP + GLP-2 injection.

OTHERPlacebo

Subcutaneous saline injection.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

(Individuals with spinal cord injury): * Spinal cord injury resulting in the need of a wheelchair * BMI: 16-32 kg/m2 Inclusion Criteria (Healthy controls): * Intact spinal cord * Matched on gender, age and BMI to the group with spinal cord injury

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
CTX	-10 to 240 minutes	Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.

Secondary

Measure	Time frame	Description
PTH	-10 to 240 minutes	PTH measured in serum PTH measured in serum
Sclerostin	-10 to 240 minutes	Bone marker
Glucose	-10 to 240 minutes	Measured in serum
Insulin	-10 to 240 minutes	Measured in serum
C-peptide	-10 to 240 minutes	Measured in serum
P1NP	-10 to 240 minutes	Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
GLP-2	-10 to 240 minutes	Glucagon-like peptide 2 measured in plasma.
Glucagon	-10 to 240 minutes	Glucagon measured in plasma
Blood pressure	-10 to 240 minutes	Measured before blood sampling
Heart rate	-10 to 240 minutes	Measured before blood sampling
GIP	-10 to 240 minutes	Glucose-dependent insulinotropic polypeptide measured in plasma

Countries

Denmark

Contacts

Primary ContactCharlotte B Christiansen, PhD

cbchristiansen@sund.ku.dk+45 22459802

Backup ContactKirsa Skov-Jeppesen, PhD

kirsa@sund.ku.dk+45 26818619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026