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NCT04465721 · ClinicalTrials.gov registry record · NA
TREAT to Improve Cardiometabolic Health
A NA study of PreDiabetes and Overweight and Obesity, sponsored by Columbia University.
- Active
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT04465721: Active NA study of PreDiabetes and Overweight and Obesity, sponsored by Columbia University.
NCT04465721 is a NA study of PreDiabetes and Overweight and Obesity that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 57 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04465721, a NA study of PreDiabetes and Overweight and Obesity, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.
Primary Outcome
Changes in fat mass (kg) will be measured by quantitative magnetic resonance (QMR) on day 0 and day 13 of ambulatory assessments at the 0 and 3 month study period, and again at 12 months.
Conditions Studied
Interventions
- BEHAVIORAL TRE
- BEHAVIORAL HABIT
Study Locations (1)
New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT04465721 still lists
NCT04465721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with PreDiabetes appearing as the primary indexed condition, and to 2 interventions - of which TRE is the first listed.
NCT04465721 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04465721 about?
NCT04465721 is a clinical study titled "TREAT to Improve Cardiometabolic Health". Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermitte...
What is the current status of trial NCT04465721?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 57 participants. The study started on 2021-06-14. Estimated completion is 2026-06-30.
What conditions does trial NCT04465721 study?
This clinical trial studies the following conditions: PreDiabetes, Overweight and Obesity.
What interventions are being tested in trial NCT04465721?
The interventions under investigation include: TRE (BEHAVIORAL), HABIT (BEHAVIORAL).
Who is sponsoring clinical trial NCT04465721?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04465721 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PreDiabetes
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 NCT04465721's enrollment target sits among peer trials
57 97th of 149 higher than 53 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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