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Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19

NCT ID: NCT03867656

Last Updated: 2020-11-04

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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GLP-2

Glucagon-like peptide 2

Group Type EXPERIMENTAL

GLP-2

Intervention Type OTHER

GLP-2 injection

GIP

Glucose-dependent insulinotropic polypeptide

Group Type EXPERIMENTAL

GIP

Intervention Type OTHER

GIP injection

Placebo

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo injection

Interventions

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GLP-2

GLP-2 injection

Intervention Type OTHER

GIP

GIP injection

Intervention Type OTHER

Placebo

Placebo injection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

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

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-Diabetes-19

Identifier Type: -

Identifier Source: org_study_id