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The Effect of Glucose on Bone - Direct og Indirect? (GLUBONE)

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ClinicalTrials.gov Identifier: NCT02213276
Recruitment Status : Unknown
Verified August 2014 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : August 11, 2014
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Glucose Infusion Bone Markers Inflammatory Markers Other: Oral Glucose Tolerance Test (OGTT) Other: Intravenous Glucose Tolerance Test (IVGTT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Glucose on Bone - Direct or Indirect?
Study Start Date : August 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Healthy males
Oral glucose tolerance test (OGTT) and intravenous glucose tolerance test (IVGTT).
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.




Primary Outcome Measures :
  1. The resorptive bone marker S-CTX. [ Time Frame: Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). ]
    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.

  2. The formative bone marker S-P1NP [ Time Frame: Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). ]
    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.


Secondary Outcome Measures :
  1. S-NTX [ Time Frame: Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). ]
    Same as for primary outcome.

  2. S-OC [ Time Frame: Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). ]
    Same as for primary outcome.

  3. RANKL. [ Time Frame: Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). ]
    Same as for primary outcomes.

  4. Inflammatory markers. [ Time Frame: Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). ]
    Same as for primary outcomes.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males
  • Aged 20 - 50 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213276


Locations
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Denmark
Department of Endocrinology and Internal Medicine
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02213276     History of Changes
Other Study ID Numbers: 2014-e1
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: August 2014
Keywords provided by University of Aarhus:
Glucose infusion
Bone markers
Inflammatory markers