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NCT03530111 · ClinicalTrials.gov registry record

Establishment of the 2H-labeling Protocol at Pennington Biomedical Research Center

A clinical trial, sponsored by Pennington Biomedical Research Center.

Completed
Registry status
11
Enrollment target

NCT03530111: Completed study, sponsored by Pennington Biomedical Research Center.

NCT03530111 is a clinical trial that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03530111 has completed, sponsored by Pennington Biomedical Research Center.

COMPLETED
Registry status
11 participants
Enrollment target

Study Summary

A method has been developed to measure in vivo adipose kinetics and turnover rates, which is a substantive departure from previous indirect and in vitro approaches. This technique involves drinking deuterium (2H)-labeled water, with an initial ramp-up to increase body water 2H enrichment, followed by daily intake to maintain enrichment values. The 2H from the heavy water is incorporated into the DNA of the dividing cells, as well as the lipid component, providing measures of cell formation, lipid synthesis, and adipose turnover. The objective of the proposed study is to enroll women who are overweight (sedentary or physically active) in order to collect 2H-enriched adipose tissue specimens that will be utilized to establish this innovative 2H-labeling protocol at Pennington Biomedical Research Center. This study will also assess adipose kinetics in individuals with different levels of physical activity to better understand the association between in vivo adipose cell kinetics, physical activity, and metabolic health in humans.

Primary Outcome

Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. Measures of DNA synthesis (obtained via gas chromatography and mass spectrometry analysis of 2H-enrichment) denote new adipose cell formation. The primary outcome is to assess adipose cell kinetic rates (i.e. synthesis) in sedentary and very physicall

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-06-20
Est. Completion 2020-02-28

What the finished NCT03530111 record still lists

NCT03530111 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT03530111 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03530111 about?

NCT03530111 is a clinical study titled "Establishment of the 2H-labeling Protocol at Pennington Biomedical Research Center". A method has been developed to measure in vivo adipose kinetics and turnover rates, which is a substantive departure from previous indirect and in vitro approaches. This technique involves drinking deuterium (2H)-labeled water, with an initial ramp-up to increase body water 2H enrichment, followed b...

What is the current status of trial NCT03530111?

This trial is currently completed. The enrollment target is 11 participants. The study started on 2018-06-20. Estimated completion is 2020-02-28.

Who is sponsoring clinical trial NCT03530111?

This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03530111, the US trial registry maintained by the National Library of Medicine. NCT03530111 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.