Diabetes, Type 1NCT01805414
Breakfast Nutrition and Inpatient Glycemia
A study testing Modified Carbohydrate Breakfast in people with Diabetes, Type 1 and Diabetes, Type 2, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 1, Diabetes, Type 2, Cardiovascular Disease
- What is being tested?
- Modified Carbohydrate Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Intensive care patients
- No intake by mouth (enteral, parenteral, NPO)
- Taking in nutrition supplements (Ensure, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Modified Carbohydrate Breakfast, Control Breakfast
- Keywords
- inpatient diabetes, inpatient diabetes nutrition
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Carbohydrate BreakfastOther
Also called Breakfast with 40-45g carbohydrates
Control BreakfastOther
Also called 40-45g carbs
| Study group | Role | What they receive |
|---|---|---|
| Intervention Breakfast | Experimental | 40-45g carbs (300-350 kcal) Receives: Other: Modified Carbohydrate Breakfast |
| Control Breakfast | Active comparator | These patients received the usual hospital breakfast which contained 40-45 g carbs. Receives: Other: Control Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in Blood sugar
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).
Measured: Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 1Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillian F Lien, MD, Principal investigator, Duke Medical CenterKathryn J Evans, NP, Study director, Duke Medical CenterMark N Feinglos, MD, Study chair, Duke Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805414
- Sponsor's protocol ID
- Pro00031605
- Status last verified
- Feb 2013
- First submitted
- 28 Feb 2013
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control
- ClinicalTrials.gov ID
- NCT01805414
- Acronym / sponsor ID
- Pro00031605
- Keywords
- inpatient diabetes, inpatient diabetes nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Breakfast | Experimental | Other: Modified Carbohydrate Breakfast40-45g carbs (300-350 kcal) |
| Control Breakfast | Active comparator | Other: Control BreakfastThese patients received the usual hospital breakfast which contained 40-45 g carbs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Intensive care patients
- No intake by mouth (enteral, parenteral, NPO)
- Taking in nutrition supplements (Ensure, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Carbohydrate BreakfastAlso: Breakfast with 40-45g carbohydrates | Other | Intervention Breakfast |
| Control BreakfastAlso: 40-45g carbs | Other | Control Breakfast |
Primary outcome
Relative change in Blood sugar
Time frame: Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian F Lien, MD principal investigator
Duke Medical Center
Kathryn J Evans, NP study director
Duke Medical Center
Mark N Feinglos, MD study chair
Duke Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Carbohydrate Breakfast in people with Diabetes, Type 1 and Diabetes, Type 2, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in Blood sugar (time frame: Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.