Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus (DLW)
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|ClinicalTrials.gov Identifier: NCT02518581|
Recruitment Status : Active, not recruiting
First Posted : August 10, 2015
Last Update Posted : January 22, 2020
The present study is an exploratory trial to establish a feasible DLW (doubly labelled water) protocol for implementation in clinical trials conducted at Profil Institut für Stoffwechselforschung, investigating treatment options for overweight and obesity in populations with and without diabetic comorbidity. The study aims at the practical validation of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects.
Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as calculated based on individual anthropometric measurements (including body composition) using the Müller formula and the AEE (activity related energy expenditure) based on reported work place and leisure time activities and (2) TEE as calculated from measured REE (resting energy expenditure) as assessed by indirect calorimetry and the AEE based on information recorded by the subjects in a physical activity diary and corresponding pedometer counts. Moreover, TEE assessments will be repeated once (separated by 2-4 weeks) to determine intra-subject variability / re-test reliability of the measurement.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Procedure: Doubly labelled water method||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Estimating Free-living Human Energy Expenditure - Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||August 12, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
|Doubly labelled water||
Procedure: Doubly labelled water method
DLW (doubly labeled water) method measures isotope dilution spaces and elimination rates to assess total energy expenditure (TEE). After enriching the body water of a subject with DLW (2H and 18O), it is only necessary to collect urine samples at defined time points, usually over a period of 1-2 weeks, so that the measurement can be done in individuals able to engage in their typical habits without restrictions. The resulting TEE measurement represents an integral value over the measurement period.
- Free-living total energy expenditure [ Time Frame: up to 3 month ]Assessed by doubly labelled water
- Resting energy expenditure [ Time Frame: up to 3 month ]Assessed by indirect calorimetry
- Activity-induced energy expenditure [ Time Frame: up to 3 month ]Assessed by diary and pedometer
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): NCT02518581
|Profil Institut für Stoffwechselforschung GmbH|
|Neuss, Germany, 41460|
|Principal Investigator:||Tim Heise, MD||Profil Institut für Stoffwechselforschung GmbH|