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NCT04558827 · ClinicalTrials.gov registry record · NA

Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics

A NA study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT04558827: Completed NA study, sponsored by University of Wisconsin, Madison.

NCT04558827 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 20 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

NCT04558827, a NA study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

The current paradigm of Type 2 Diabetes treatment relies heavily on expensive pharmacotherapy even though lifestyle factors are at the root of the condition. This study is designed to assess the feasibility of a low carbohydrate diet coupled with a time restricted feeding intervention to improve participant sensitivity, reducing their need for insulin. 20 participants will be invited to enroll from the 20 S Park St Clinic in Madison, WI and remain on study for up to 6 months.

Primary Outcome

Changes in A1c will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review. Comparisons will be made between post-intervention A1c scores and baseline scores, at 1 month and at 3 months using paired t-tests to detect whether patients experienced a positive outcome.

Interventions

  • OTHER Low Carbohydrate Diet
  • OTHER Time Restricted Feeding

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-02-01
Est. Completion 2022-01-24
Phase NA
University of Wisconsin, Madison

1,039 total trials

What the finished NCT04558827 record still lists

NCT04558827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 is the first listed.

NCT04558827 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04558827 about?

NCT04558827 is a clinical study titled "Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics". The current paradigm of Type 2 Diabetes treatment relies heavily on expensive pharmacotherapy even though lifestyle factors are at the root of the condition. This study is designed to assess the feasibility of a low carbohydrate diet coupled with a time restricted feeding intervention to improve par...

What is the current status of trial NCT04558827?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2021-02-01. Estimated completion is 2022-01-24.

What interventions are being tested in trial NCT04558827?

The interventions under investigation include: Low Carbohydrate Diet (OTHER), Time Restricted Feeding (OTHER).

Who is sponsoring clinical trial NCT04558827?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04558827's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 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 NCT04558827, the US trial registry maintained by the National Library of Medicine. NCT04558827 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.