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NCT04829110 · ClinicalTrials.gov registry record · NA

Alcohol Induced de Novo Lipogenesis in Women

A NA study of Liver Metabolism, sponsored by University of Texas Southwestern Medical Center.

Active
Registry status
NA
Development phase
27
Enrollment target
1
Study location

NCT04829110: Active NA study of Liver Metabolism, sponsored by University of Texas Southwestern Medical Center.

NCT04829110 is a NA study of Liver Metabolism that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04829110, a NA study of Liver Metabolism, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
27 participants
Enrollment target
1
Study location

Study Summary

The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of \[2H\]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.

Primary Outcome

DNL will be measured by Orbitrap high-resolution-mass-spectrometry (GC-Orbitrap-HRMS) We will measure changes in the incorporation of 2H tracers into plasma triglycerides over time. This data will be analyzed by averaging each time point and looking at change in de novo lipogenesis over time.

Conditions Studied

Interventions

  • OTHER ETOH
  • OTHER Sucrose

Study Locations (1)

Texas

  • School of Health Professions at UTSW - Dallas

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2021-11-11
Est. Completion 2026-03-31
Phase NA

What the registry record for NCT04829110 still lists

NCT04829110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Liver Metabolism appearing as the primary indexed condition, and to 2 interventions - of which ETOH is the first listed.

NCT04829110 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT04829110 about?

NCT04829110 is a clinical study titled "Alcohol Induced de Novo Lipogenesis in Women". The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of \[2H\]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and ...

What is the current status of trial NCT04829110?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 27 participants. The study started on 2021-11-11. Estimated completion is 2026-03-31.

What conditions does trial NCT04829110 study?

This clinical trial studies the following conditions: Liver Metabolism.

What interventions are being tested in trial NCT04829110?

The interventions under investigation include: ETOH (OTHER), Sucrose (OTHER).

Who is sponsoring clinical trial NCT04829110?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04829110 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04829110's enrollment target sits among peer trials

27 1708th of 2000 higher than 291 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04829110, the US trial registry maintained by the National Library of Medicine. NCT04829110 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.