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NCT03544892 · ClinicalTrials.gov registry record · NA
The Effects of a Low Carbohydrate, Non-Ketogenic Diet Versus Standard Diabetes Diet on Glycemic Control in Type 1 Diabetes
A NA study, sponsored by University of Oklahoma.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03544892: Clinical Trial NA study, sponsored by University of Oklahoma.
NCT03544892 is a NA study that was terminated before completion, run by University of Oklahoma. 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.
The verdict
NCT03544892, a NA study, was terminated before completion, sponsored by University of Oklahoma.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
This randomized, crossover nutrition intervention seeks to examine the effects of a non-ketogenic low carbohydrate (CHO) diet (60-80g per day) on glycemic control, lipids, and markers on inflammation in individuals with Type 1 Diabetes (T1D). This study will be used to inform clinical practice, especially in teaching medical nutrition therapy to new-onset diabetes patients and those struggling with glycemic control and hyperlipidemia. At this time, no evidenced-based universal recommendations from randomized controlled trials exist to support low carbohydrate dietary patterns as a front-line approach in individuals with T1D. The investigators hypothesize a diet consisting of 60-80 g carbohydrate diet will result in greater improvement in glycemic control compared to a 50% carbohydrate diet in patients with Type 1 diabetes over 12 weeks in the outpatient setting.
Primary Outcome
Difference in time spent with glucose values between 70-180 mg/dL assessed by continuous glucose monitoring (CGM)
Interventions
- OTHER Low carbohydrate diet
- OTHER Standard of care diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2019-06-28 |
| Phase | NA |
Why NCT03544892 stopped before completion
NCT03544892 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 is the first listed.
NCT03544892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03544892 about?
NCT03544892 is a clinical study titled "The Effects of a Low Carbohydrate, Non-Ketogenic Diet Versus Standard Diabetes Diet on Glycemic Control in Type 1 Diabetes". This randomized, crossover nutrition intervention seeks to examine the effects of a non-ketogenic low carbohydrate (CHO) diet (60-80g per day) on glycemic control, lipids, and markers on inflammation in individuals with Type 1 Diabetes (T1D). This study will be used to inform clinical practice, espe...
What is the current status of trial NCT03544892?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2018-05-01. Estimated completion is 2019-06-28.
What interventions are being tested in trial NCT03544892?
The interventions under investigation include: Low carbohydrate diet (OTHER), Standard of care diet (OTHER).
Who is sponsoring clinical trial NCT03544892?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03544892'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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