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NCT04045353 · ClinicalTrials.gov registry record · NA

A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth

A NA study, sponsored by The University of Texas Medical Branch, Galveston.

Terminated
Registry status
NA
Development phase
11
Enrollment target

NCT04045353: Clinical Trial NA study, sponsored by The University of Texas Medical Branch, Galveston.

NCT04045353 is a NA study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04045353, a NA study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.

TERMINATED
Registry status
NA
Development phase
11 participants
Enrollment target

Study Summary

The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women.

Primary Outcome

Homeostatic model assessment for measurement of insulin sensitivity will be computed with fasting insulin and glucose levels (fasting for at least 8 hours) with the following calculation: (glucose x insulin/22.5). This calculation is measured in molar units (mmol/L).

Interventions

  • BEHAVIORAL Low carbohydrate diet education
  • BEHAVIORAL Low carbohydrate diet education with behavioral component

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2019-12-20
Est. Completion 2022-07-01
Phase NA

Why NCT04045353 stopped before completion

NCT04045353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Low carbohydrate diet education is the first listed.

NCT04045353 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04045353 about?

NCT04045353 is a clinical study titled "A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth". The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women.

What is the current status of trial NCT04045353?

This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2019-12-20. Estimated completion is 2022-07-01.

What interventions are being tested in trial NCT04045353?

The interventions under investigation include: Low carbohydrate diet education (BEHAVIORAL), Low carbohydrate diet education with behavioral component (BEHAVIORAL).

Who is sponsoring clinical trial NCT04045353?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04045353's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 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 NCT04045353, the US trial registry maintained by the National Library of Medicine. NCT04045353 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.