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Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism. (KS-4-HypoPT)

Primary Purpose

Hypoparathyroidism

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Liquid meal (Nutridrink)
GIP
GLP-2
Placebo (saline)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoparathyroidism focused on measuring hypoparathyroidism, Glucose-dependent insulinotropic polypeptide (GIP), Glucagon-like peptide-2 (GLP-2), Bone remodeling, Bone resorption, Bone formation, C-terminal telopeptide (CTX), N-terminal propeptide of type 1 procollagen (P1NP)

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 76
  • Hypoparathyroidism

Exclusion Criteria:

  • Diabetes
  • Disease in the gastrointestinal tract
  • Antiosteoporotic drug
  • Long term steroid treatment (within the last 12 months)
  • Pregnancy

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Liquid meal (Nutridrink)

GIP

GLP-2

Placebo (saline)

Arm Description

Liquid meal (Nutridrink)

Glucose-dependent insulinotropic polypeptide

Glucagon-like peptide-2

Placebo (saline)

Outcomes

Primary Outcome Measures

Serum concentration of C-terminal telopeptide (CTX)
Marker of bone resorption, measured in serum
N-terminal propeptide of type 1 procollagen (P1NP)
Marker of bone formation, concentration measured in serum

Secondary Outcome Measures

PTH
PTH concentration measured in serum
Glucose-dependent insulinotropic polypeptide (GIP)
Gut hormone, concentration measured in plasma
Glucagon-like peptide-2 (GLP-2)
Gut hormone, concentration measured in plasma
Glucagon-like peptide-1 (GLP-1)
Gut hormone, concentration measured in plasma
Glucose
Glucose concentration measured in serum
Insulin
Insulin concentration measured in serum
C-peptide
C-peptide concentration measured in serum

Full Information

First Posted
October 31, 2018
Last Updated
December 11, 2019
Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03728959
Brief Title
Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.
Acronym
KS-4-HypoPT
Official Title
Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism (KS-4-HypoPT).
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
April 12, 2019 (Actual)
Study Completion Date
April 12, 2019 (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
Hypoparathyroidism (hypoPT) is characterized by low levels of PTH. In this study we will test the effects of a liquid meal on the bone remodeling in participants with hypoparathyroidism. Furthermore, we will test the effects of the gut hormones GIP and GLP-2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoparathyroidism
Keywords
hypoparathyroidism, Glucose-dependent insulinotropic polypeptide (GIP), Glucagon-like peptide-2 (GLP-2), Bone remodeling, Bone resorption, Bone formation, C-terminal telopeptide (CTX), N-terminal propeptide of type 1 procollagen (P1NP)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Liquid meal (Nutridrink)
Arm Type
Experimental
Arm Description
Liquid meal (Nutridrink)
Arm Title
GIP
Arm Type
Experimental
Arm Description
Glucose-dependent insulinotropic polypeptide
Arm Title
GLP-2
Arm Type
Experimental
Arm Description
Glucagon-like peptide-2
Arm Title
Placebo (saline)
Arm Type
Experimental
Arm Description
Placebo (saline)
Intervention Type
Other
Intervention Name(s)
Liquid meal (Nutridrink)
Intervention Description
Liquid meal ingested over 1 minute.
Intervention Type
Other
Intervention Name(s)
GIP
Intervention Description
Subcutaneous injected GIP
Intervention Type
Other
Intervention Name(s)
GLP-2
Intervention Description
Subcutaneous injected GLP-2
Intervention Type
Other
Intervention Name(s)
Placebo (saline)
Intervention Description
Subcutaneous injected Placebo (saline)
Primary Outcome Measure Information:
Title
Serum concentration of C-terminal telopeptide (CTX)
Description
Marker of bone resorption, measured in serum
Time Frame
-10 to 240 minutes
Title
N-terminal propeptide of type 1 procollagen (P1NP)
Description
Marker of bone formation, concentration measured in serum
Time Frame
-10 to 240 minutes
Secondary Outcome Measure Information:
Title
PTH
Description
PTH concentration measured in serum
Time Frame
-10 to 240 minutes
Title
Glucose-dependent insulinotropic polypeptide (GIP)
Description
Gut hormone, concentration measured in plasma
Time Frame
-10 to 240 minutes
Title
Glucagon-like peptide-2 (GLP-2)
Description
Gut hormone, concentration measured in plasma
Time Frame
-10 to 240 minutes
Title
Glucagon-like peptide-1 (GLP-1)
Description
Gut hormone, concentration measured in plasma
Time Frame
-10 to 240 minutes
Title
Glucose
Description
Glucose concentration measured in serum
Time Frame
-10 to 240 minutes
Title
Insulin
Description
Insulin concentration measured in serum
Time Frame
-10 to 240 minutes
Title
C-peptide
Description
C-peptide concentration measured in serum
Time Frame
-10 to 240 minutes
Other Pre-specified Outcome Measures:
Title
Blood pressure
Description
Blood pressure (systolic and diastolic) measured before blood sampling
Time Frame
-10 to 240 minutes
Title
Heart rate
Description
Heart rate 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
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 76 Hypoparathyroidism Exclusion Criteria: Diabetes Disease in the gastrointestinal tract Antiosteoporotic drug Long term steroid treatment (within the last 12 months) Pregnancy
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
Undecided

Learn more about this trial

Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.

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