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The Effect of Glucose on Bone - Direct og Indirect?

NCT02213276 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-06-10

No results posted yet for this study

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.

Conditions

  • Glucose Infusion
  • Bone Markers
  • Inflammatory Markers

Interventions

OTHER

Oral Glucose Tolerance Test (OGTT)

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.

OTHER

Intravenous Glucose Tolerance Test (IVGTT)

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.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-07-31
Completion
2017-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02213276 on ClinicalTrials.gov