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Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Meal test
GIP
GLP-2
GIP + GLP-2
Placebo
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries focused on measuring Spinal cord injury, GIP, GLP-2, CTX, P1NP, Bone resorption, Bone formation, Bone turnover, Bone remodeling

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hvidovre University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Meal test

GIP, Glucose-dependent insulinotropic polypeptide

GLP-2, Glucagon-like-peptide-2

GIP + GLP-2

Placebo (saline)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2021
Last Updated
May 9, 2023
Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05181150
Brief Title
Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury
Official Title
Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal cord injury, GIP, GLP-2, CTX, P1NP, Bone resorption, Bone formation, Bone turnover, Bone remodeling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meal test
Arm Type
Experimental
Arm Title
GIP, Glucose-dependent insulinotropic polypeptide
Arm Type
Experimental
Arm Title
GLP-2, Glucagon-like-peptide-2
Arm Type
Experimental
Arm Title
GIP + GLP-2
Arm Type
Experimental
Arm Title
Placebo (saline)
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Meal test
Other Intervention Name(s)
Nutridrink
Intervention Description
Ingestion of an oral liquid meal (nutridrink), 200 mL.
Intervention Type
Other
Intervention Name(s)
GIP
Intervention Description
Subcutaneous GIP injection.
Intervention Type
Other
Intervention Name(s)
GLP-2
Intervention Description
Subcutaneous GLP-2 injection.
Intervention Type
Other
Intervention Name(s)
GIP + GLP-2
Intervention Description
Subcutaneous GIP + GLP-2 injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous saline injection.
Primary Outcome Measure Information:
Title
CTX
Description
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
Time Frame
-10 to 240 minutes
Secondary Outcome Measure Information:
Title
P1NP
Description
Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
Time Frame
-10 to 240 minutes
Title
PTH
Description
PTH measured in serum PTH measured in serum
Time Frame
-10 to 240 minutes
Title
Sclerostin
Description
Bone marker
Time Frame
-10 to 240 minutes
Title
Glucose
Description
Measured in serum
Time Frame
-10 to 240 minutes
Title
Insulin
Description
Measured in serum
Time Frame
-10 to 240 minutes
Title
C-peptide
Description
Measured in serum
Time Frame
-10 to 240 minutes
Title
GIP
Description
Glucose-dependent insulinotropic polypeptide measured in plasma
Time Frame
-10 to 240 minutes
Title
GLP-2
Description
Glucagon-like peptide 2 measured in plasma.
Time Frame
-10 to 240 minutes
Title
Glucagon
Description
Glucagon measured in plasma
Time Frame
-10 to 240 minutes
Title
Blood pressure
Description
Measured before blood sampling
Time Frame
-10 to 240 minutes
Title
Heart rate
Description
Measured before blood sampling
Time Frame
-10 to 240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte B Christiansen, PhD
Phone
+45 22459802
Email
cbchristiansen@sund.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsa Skov-Jeppesen, PhD
Phone
+45 26818619
Email
kirsa@sund.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette M Rosenkilde, Prof., MD
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sten Madsbad
Email
Sten.Madsbad@regionh.dk
First Name & Middle Initial & Last Name & Degree
Charlotte B Christiansen
Email
cbchristiansen@sund.ku.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

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