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Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus

NCT02518581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-12-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    lead INDUSTRY

Principal Investigators

  • Tim Heise, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-12
Primary Completion
2021-12-23
Completion
2021-12-23

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT02518581 on ClinicalTrials.gov