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NCT03504683 · ClinicalTrials.gov registry record · NA
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
A NA study of PreDiabetes, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT03504683: Recruiting NA study of PreDiabetes, sponsored by University of Alabama at Birmingham.
NCT03504683 is a NA study of PreDiabetes that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 144 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03504683, a NA study of PreDiabetes, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
Study Summary
One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between \~8 am-3 pm), (2) 'Mid-day TRE' (eat between \~1 pm - 8 pm), or (3) Control Schedule (\~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.
Primary Outcome
Mean 24-hour glucose levels (mg/dl)
Conditions Studied
Interventions
- BEHAVIORAL Early TRE
- BEHAVIORAL Mid-day TRE
- BEHAVIORAL Control Schedule
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2020-08-17 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What NCT03504683 shows while recruiting
NCT03504683 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (79% lower).
The record links to 1 condition, with PreDiabetes appearing as the primary indexed condition, and to 3 interventions - of which Early TRE is the first listed.
NCT03504683 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT03504683 about?
NCT03504683 is a clinical study titled "MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes". One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in...
What is the current status of trial NCT03504683?
This trial is currently recruiting. It is a NA study. The enrollment target is 144 participants. The study started on 2020-08-17. Estimated completion is 2025-12-31.
What conditions does trial NCT03504683 study?
This clinical trial studies the following conditions: PreDiabetes.
What interventions are being tested in trial NCT03504683?
The interventions under investigation include: Early TRE (BEHAVIORAL), Mid-day TRE (BEHAVIORAL), Control Schedule (BEHAVIORAL).
Who is sponsoring clinical trial NCT03504683?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03504683 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03504683's enrollment target sits among peer trials
144 51st of 149 higher than 99 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes 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.
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