Breakfast Nutrition and Inpatient Glycemia
The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control
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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adults with cardiovascular disease who were admitted to 2 pre-specified wards at Duke Medical Center during the study period
- Diagnosis of diabetes (type 1 or 2) or newly identified hyperglycemia (blood glucose of >200 on 2 separate occasions)
- Able to consume food by mouth
Exclusion Criteria:
- Intensive care patients
- No intake by mouth (enteral, parenteral, NPO)
- Taking in nutrition supplements (Ensure, etc)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention Breakfast
40-45g carbs (300-350 kcal)
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Andre navne:
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Aktiv komparator: Control Breakfast
These patients received the usual hospital breakfast which contained 40-45 g carbs.
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Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Relative change in Blood sugar
Tidsramme: Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.
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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) minus BG1 (pre-breakfast). |
Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lillian F Lien, MD, Duke Medical Center
- Studieleder: Kathryn J Evans, NP, Duke Medical Center
- Studiestol: Mark N Feinglos, MD, Duke Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00031605
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