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NCT03758742 · ClinicalTrials.gov registry record · NA
Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT03758742: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT03758742 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 34 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
NCT03758742, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
Diabetes costs the U.S. healthcare system more than any other disease, and nearly half of Americans will develop either diabetes or prediabetes in their lifetime. It is therefore critical to find new strategies to treat or reverse diabetes. One such approach is adopting a healthy diet, which can dramatically improve blood sugar levels in adults with type 2 diabetes and even induce diabetes remission. Despite this, not much is known about which food groups are most effective at improving blood sugar levels in patients with diabetes. Interestingly, of the various food groups, epidemiologic data suggests that whole fruit may be one of the most efficacious at both preventing type 2 diabetes and improving blood sugar in patients with type 2 diabetes. However, few clinical trials have investigated the effects of whole fruit on blood sugar control. This study will therefore be the first to determine the effects of increasing whole fruit as a food group in type 2 diabetes patients. This supervised controlled feeding trial will test whether consuming a diet rich in whole fruit for 12 weeks can improve glycemic control and cardiometabolic health in weight-stable adults with type 2 diabetes. The primary endpoint is glycemic control. Since changes in medication doses can skew the interpretation of glycemic outcomes, glycemic control will be assessed hierarchically (in descending order of importance) using (a) attainment of nondiabetic glycemia without medications (as a proxy for diabetes remission), (b) medication effect scores, (c) mean glucose during an oral glucose tolerance test, and (d) 24-hour mean glucose from continuous glucose monitoring. As secondary aims, this study will also test whether consuming a large amount of fructose in whole food form affects liver fat, pancreatic fat, and cardiovascular disease risk factors.
Primary Outcome
Percentage of patients who can maintain non-diabetic levels 24-hour mean glucose without the aid of pharmacotherapy at week 12
Interventions
- BEHAVIORAL High-Fruit Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-09-10 |
| Est. Completion | 2023-09-05 |
| Phase | NA |
What the finished NCT03758742 record still lists
NCT03758742 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 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 High-Fruit Diet is the first listed.
NCT03758742 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03758742 about?
NCT03758742 is a clinical study titled "Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes". Diabetes costs the U.S. healthcare system more than any other disease, and nearly half of Americans will develop either diabetes or prediabetes in their lifetime. It is therefore critical to find new strategies to treat or reverse diabetes. One such approach is adopting a healthy diet, which can dr...
What is the current status of trial NCT03758742?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2019-09-10. Estimated completion is 2023-09-05.
What interventions are being tested in trial NCT03758742?
The interventions under investigation include: High-Fruit Diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT03758742?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03758742's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 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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