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NCT01805414 · ClinicalTrials.gov registry record · NA
Breakfast Nutrition and Inpatient Glycemia
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 237
- Enrollment target
NCT01805414: Completed NA study, sponsored by Duke University.
NCT01805414 is a NA study that has completed, run by Duke University. The registered enrollment target is 237 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805414, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 237 participants
- Enrollment target
Study Summary
A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may not be ideal for patients with diabetes. This concern is particularly pertinent to the breakfast meal, which often contains mainly CHO. Clinical observations suggested that such diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital "no concentrated sweets (NCS)" breakfast meals with more balanced meals. The study team hypothesized that a balanced breakfast would improve pre-lunch BG values. This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD). Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All patients on Ward A (with and without diabetes) were given the intervention breakfast for the first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS meals). After 4 weeks, the standard and intervention wards were switched. Data were collected only on patients with diabetes who were able to consume meals.
Primary Outcome
The primary outcome will be the relative change between the pre-breakfast and pre-lunch blood glucose levels after the intervention breakfast. The hypothesis is that the intervention breakfast will lead to lower pre-lunch blood sugars. Blood glucoses will be measured before breakfast and lunch on eligible patients. This will occur every day for the duration of the study (8 weeks). The relative change between the pre-breakfast and pre-lunch blood glucose will be assessed by BG2 (pre-lunch) minu
Interventions
- OTHER Modified Carbohydrate Breakfast
- OTHER Control Breakfast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-11 |
| Phase | NA |
What the finished NCT01805414 record still lists
NCT01805414 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Modified Carbohydrate Breakfast is the first listed.
NCT01805414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805414 about?
NCT01805414 is a clinical study titled "Breakfast Nutrition and Inpatient Glycemia". A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may not be ideal for patients with diabetes. This concern is particularly pertinent to the breakfast meal, which often contains mainly CHO. Clinical observations suggested that such diets elevate pre-lunch blood ...
What is the current status of trial NCT01805414?
This trial is currently completed. It is a NA study. The enrollment target is 237 participants. The study started on 2012-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01805414?
The interventions under investigation include: Modified Carbohydrate Breakfast (OTHER), Control Breakfast (OTHER).
Who is sponsoring clinical trial NCT01805414?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01805414's enrollment target sits among peer trials
237 461st of 2000 higher than 1,540 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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