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NCT05161897 · ClinicalTrials.gov registry record · NA
Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
A NA study, sponsored by George Mason University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT05161897: Completed NA study, sponsored by George Mason University.
NCT05161897 is a NA study that has completed, run by George Mason University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05161897, a NA study, has completed, sponsored by George Mason University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (SOC). The hypothesis is that the INT arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (HOMA) in individuals with prediabetes. Secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.
Primary Outcome
Evaluating change in 24hr interstitial glucose concentrations and glycemic variability from baseline measure using a Continuous Glucose Monitoring (CGM) device
Interventions
- OTHER Individualized Nutrition Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2023-12-14 |
| Phase | NA |
What the finished NCT05161897 record still lists
NCT05161897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Individualized Nutrition Therapy is the first listed.
NCT05161897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05161897 about?
NCT05161897 is a clinical study titled "Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes". The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce ...
What is the current status of trial NCT05161897?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2022-08-25. Estimated completion is 2023-12-14.
What interventions are being tested in trial NCT05161897?
The interventions under investigation include: Individualized Nutrition Therapy (OTHER).
Who is sponsoring clinical trial NCT05161897?
This trial is sponsored by George Mason University, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05161897's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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