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

December 11, 2019 updated by: Kirsa Skov-Jeppesen, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liquid meal (Nutridrink)
Other: Liquid meal (Nutridrink)
Liquid meal ingested over 1 minute.
EXPERIMENTAL: GIP
Glucose-dependent insulinotropic polypeptide
Other: GIP
Subcutaneous injected GIP
EXPERIMENTAL: GLP-2
Glucagon-like peptide-2
Other: GLP-2
Subcutaneous injected GLP-2
EXPERIMENTAL: Placebo (saline)
Other: Placebo (saline)
Subcutaneous injected Placebo (saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentration of C-terminal telopeptide (CTX)
Time Frame: -10 to 240 minutes
Marker of bone resorption, measured in serum
-10 to 240 minutes
N-terminal propeptide of type 1 procollagen (P1NP)
Time Frame: -10 to 240 minutes
Marker of bone formation, concentration measured in serum
-10 to 240 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTH
Time Frame: -10 to 240 minutes
PTH concentration measured in serum
-10 to 240 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Time Frame: -10 to 240 minutes
Gut hormone, concentration measured in plasma
-10 to 240 minutes
Glucagon-like peptide-2 (GLP-2)
Time Frame: -10 to 240 minutes
Gut hormone, concentration measured in plasma
-10 to 240 minutes
Glucagon-like peptide-1 (GLP-1)
Time Frame: -10 to 240 minutes
Gut hormone, concentration measured in plasma
-10 to 240 minutes
Glucose
Time Frame: -10 to 240 minutes
Glucose concentration measured in serum
-10 to 240 minutes
Insulin
Time Frame: -10 to 240 minutes
Insulin concentration measured in serum
-10 to 240 minutes
C-peptide
Time Frame: -10 to 240 minutes
C-peptide concentration measured in serum
-10 to 240 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: -10 to 240 minutes
Blood pressure (systolic and diastolic) measured before blood sampling
-10 to 240 minutes
Heart rate
Time Frame: -10 to 240 minutes
Heart rate measured before blood sampling
-10 to 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2018

Primary Completion (ACTUAL)

April 12, 2019

Study Completion (ACTUAL)

April 12, 2019

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (ACTUAL)

November 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS-4-HypoPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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