Gut Peptides and Bone Remodeling in Individuals With Spin... | NCT05181150

Studies
Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

NCT05181150

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

May 10, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Spinal Cord Injuries

Interventions

Meal test
GIP
GLP-2
GIP + GLP-2
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2021Actual

Primary Completion Date

Nov 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Dec 18, 2021

First Submission Date that Met QC Criteria

Dec 18, 2021

First Posted Date

Jan 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2023

Last Update Posted Date

May 10, 2023Actual

Name	Class
Hvidovre University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Meal test	Other	Ingestion of an oral liquid meal (nutridrink), 200 mL.	Meal test

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
P1NP	Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.	-10 to 240 minutes
PTH	PTH measured in serum PTH measured in serum

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charlotte B Christiansen, PhD	Contact	+45 22459802		cbchristiansen@sund.ku.dk
Kirsa Skov-Jeppesen, PhD	Contact	+45 26818619		kirsa@sund.ku.dk

Overall Officials

Name	Affiliation	Role
Mette M Rosenkilde, Prof., MD	University of Copenhagen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital	Recruiting	Hvidovre		2650	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D001862	Bone Resorption

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided