Back to resultsEffects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GLP-2
GIP
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Bone resorption, Bone formation, CTX, P1NP, GLP-2, GIP, Bone turnover, Bone remodeling
Eligibility Criteria
Inclusion Criteria:
- Male
- Age 25 to 70 years old.
- Type 2 diabetes.
- In Metformin or sulfonylureas
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
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
GLP-2
GIP
Placebo
Arm Description
Glucagon-like peptide 2
Glucose-dependent insulinotropic polypeptide
Saline
Outcomes
Primary Outcome Measures
CTX
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
P1NP
Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
Secondary Outcome Measures
PTH
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
NCT ID
NCT03867656
First Posted
March 5, 2019
Last Updated
November 3, 2020
Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03867656
Brief Title
Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Official Title
Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Bone resorption, Bone formation, CTX, P1NP, GLP-2, GIP, Bone turnover, Bone remodeling
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLP-2
Arm Type
Experimental
Arm Description
Glucagon-like peptide 2
Arm Title
GIP
Arm Type
Experimental
Arm Description
Glucose-dependent insulinotropic polypeptide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Other
Intervention Name(s)
GLP-2
Intervention Description
GLP-2 injection
Intervention Type
Other
Intervention Name(s)
GIP
Intervention Description
GIP injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo injection
Primary Outcome Measure Information:
Title
CTX
Description
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
Time Frame
-10 minutes to 240 minutes
Title
P1NP
Description
Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
Time Frame
-10 minutes to 240 minutes
Secondary Outcome Measure Information:
Title
PTH
Description
PTH measured in serum
Time Frame
-10 minutes to 240 minutes
Title
Sclerostin
Description
Bone marker.
Time Frame
-10 min to 240 min.
Title
Glucose
Description
Measured in serum
Time Frame
-10 minutes to 240 minutes
Title
Insulin
Description
Measured in serum
Time Frame
-10 minutes to 240 minutes
Title
C-peptide
Description
Measured in serum
Time Frame
-10 minutes to 240 minutes
Title
GIP
Description
Glucose-dependent insulinotropic polypeptide measured in plasma.
Time Frame
-10 minutes to 240 minutes
Title
GLP-2
Description
Glucagon-like peptide 2 measured in plasma.
Time Frame
-10 minutes to 240 minutes
Title
Glucagon
Description
Glucagon measured in plasma
Time Frame
-10 minutes to 240 minutes
Title
Blood pressure
Description
Measured before blood sampling
Time Frame
-10 minutes to 240 minutes
Title
Heart rate
Description
Measured before blood sampling
Time Frame
-10 minutes to 240 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
Age 25 to 70 years old.
Type 2 diabetes.
In Metformin or sulfonylureas
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Rosenkilde, 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
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
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