NCT02213276

Brief Summary

Diabetes is associated with an increased risk of bone fractures, but current predictors of bone fracture seem to underestimate this risk. It is commonly known that increased levels of certain biochemical bone markers predict low-energy fractures, but the pattern of these markers in diabetics still show heterogeneity and inconsistency. Part of the pathology of diabetes is a high blood glucose level, and this can potentially influence bone turnover and thereby bone markers. Chronic inflammation in patients with inflammatory bowel disease is shown to increase bone resorption, and the same may be the case in diabetics. The purpose of this project is to investigate whether glucose has a direct effect on bone markers or an indirect effect through intestinal hormones or inflammatory processes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 10, 2015

Status Verified

August 1, 2014

Enrollment Period

1.9 years

First QC Date

August 7, 2014

Last Update Submit

June 9, 2015

Conditions

Glucose InfusionBone MarkersInflammatory Markers

Keywords

Glucose infusionBone markersInflammatory markers

Outcome Measures

Primary Outcomes (2)

  • The resorptive bone marker S-CTX.

    This outcome will be measured for both the oral glucose tolerance test and the intravenous glucose tolerance test, in order to detect differences in bone marker status.

    Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours).

  • The formative bone marker S-P1NP

    This outcome will be measured for both the oral glucose tolerance test and the intravenous glucose tolerance test, in order to detect differences in bone marker status.

    Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours).

Secondary Outcomes (4)

  • S-NTX

    Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours).

  • S-OC

    Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours).

  • RANKL.

    Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours).

  • Inflammatory markers.

    Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours).

Study Arms (1)

Healthy males

EXPERIMENTAL

Oral glucose tolerance test (OGTT) and intravenous glucose tolerance test (IVGTT).

Other: Oral Glucose Tolerance Test (OGTT)Other: Intravenous Glucose Tolerance Test (IVGTT)

Interventions

Oral Glucose Tolerance Test (OGTT)OTHER

At baseline participants are asked to drink a glucose solution consisting of 75 grams of glucose dissolved in 250 ml of water. Meanwhile and 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours later, blood is collected from an intravenous access, in order to asses primary and secondary outcomes.

Healthy males
Intravenous Glucose Tolerance Test (IVGTT)OTHER

In this intervention, the participant needs to have two intravenous accesses. In one we infuse an adjustable 20% glucose solution, and try to mimic the glucose profile found in the oral glucose tolerance test. In order to do this, blood glucose is measured every 5 minutes. At baseline and 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours later, blood is collected from another intravenous access, in order to asses primary and secondary outcomes.

Healthy males

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males
  • Aged 20 - 50 years

You may not qualify if:

  • Chronic diseases, including diabetes, but not allergies
  • Daily medication use
  • Daily dietary supplement use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Yan X, Wang Z, Westberg-Rasmussen S, Tarbier M, Rathjen T, Tattikota SG, Peck BCE, Kanke M, Oxvig C, Frystyk J, Starup-Linde J, Sethupathy P, Friedlander MR, Gregersen S, Poy MN. Differential Impact of Glucose Administered Intravenously and Orally on Circulating miR-375 Levels in Human Subjects. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3749-3755. doi: 10.1210/jc.2017-01365.

    PMID: 28973164DERIVED

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 11, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

June 10, 2015

Record last verified: 2014-08

Locations

DK(1)