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

NCT ID: NCT03728959

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2019-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoparathyroidism

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Liquid meal (Nutridrink)

Liquid meal (Nutridrink)

Group Type EXPERIMENTAL

Liquid meal (Nutridrink)

Intervention Type OTHER

Liquid meal ingested over 1 minute.

GIP

Glucose-dependent insulinotropic polypeptide

Group Type EXPERIMENTAL

GIP

Intervention Type OTHER

Subcutaneous injected GIP

GLP-2

Glucagon-like peptide-2

Group Type EXPERIMENTAL

GLP-2

Intervention Type OTHER

Subcutaneous injected GLP-2

Placebo (saline)

Placebo (saline)

Group Type EXPERIMENTAL

Placebo (saline)

Intervention Type OTHER

Subcutaneous injected Placebo (saline)

Interventions

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Liquid meal (Nutridrink)

Liquid meal ingested over 1 minute.

Intervention Type OTHER

GIP

Subcutaneous injected GIP

Intervention Type OTHER

GLP-2

Subcutaneous injected GLP-2

Intervention Type OTHER

Placebo (saline)

Subcutaneous injected Placebo (saline)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Kirsa Skov-Jeppesen

principal investigator. Cand.pharm., ph.d. student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette Rosenkilde, MD

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KS-4-HypoPT

Identifier Type: -

Identifier Source: org_study_id