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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02213276
Other study ID # 2014-e1
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 7, 2014
Last updated June 9, 2015
Start date August 2014
Est. completion date July 2017

Study information

Verified date August 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Comite (De Videnskabsetiske Komiteer For Region Midtjylland)
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Denmark Department of Endocrinology and Internal Medicine Aarhus Aarhus C

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). No
Primary 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). No
Secondary S-NTX Same as for primary outcome. Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). No
Secondary S-OC Same as for primary outcome. Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). No
Secondary RANKL. Same as for primary outcomes. Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). No
Secondary Inflammatory markers. Same as for primary outcomes. Change from baseline (at 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours). No
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