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

November 3, 2020 updated by: Kirsa Skov-Jeppesen, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Saline
Other: Placebo
Placebo injection
Experimental: GLP-2
Glucagon-like peptide 2
Other: GLP-2
GLP-2 injection
Experimental: GIP
Glucose-dependent insulinotropic polypeptide
Other: GIP
GIP injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CTX
Time Frame: -10 minutes to 240 minutes
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
-10 minutes to 240 minutes
P1NP
Time Frame: -10 minutes to 240 minutes
Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
-10 minutes to 240 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTH
Time Frame: -10 minutes to 240 minutes
PTH measured in serum
-10 minutes to 240 minutes
Sclerostin
Time Frame: -10 min to 240 min.
Bone marker.
-10 min to 240 min.
Glucose
Time Frame: -10 minutes to 240 minutes
Measured in serum
-10 minutes to 240 minutes
Insulin
Time Frame: -10 minutes to 240 minutes
Measured in serum
-10 minutes to 240 minutes
C-peptide
Time Frame: -10 minutes to 240 minutes
Measured in serum
-10 minutes to 240 minutes
GIP
Time Frame: -10 minutes to 240 minutes
Glucose-dependent insulinotropic polypeptide measured in plasma.
-10 minutes to 240 minutes
GLP-2
Time Frame: -10 minutes to 240 minutes
Glucagon-like peptide 2 measured in plasma.
-10 minutes to 240 minutes
Glucagon
Time Frame: -10 minutes to 240 minutes
Glucagon measured in plasma
-10 minutes to 240 minutes
Blood pressure
Time Frame: -10 minutes to 240 minutes
Measured before blood sampling
-10 minutes to 240 minutes
Heart rate
Time Frame: -10 minutes to 240 minutes
Measured before blood sampling
-10 minutes 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)

February 26, 2019

Primary Completion (Actual)

June 26, 2020

Study Completion (Actual)

June 26, 2020

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS-4-Diabetes-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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