- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02982330
Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes
October 12, 2017 updated by: Jonathan Little, University of British Columbia
Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to sustained hyperglycaemia across the day.
Lowering consumption of dietary carbohydrate is known to reduce post-meal glucose excursions but it is unknown whether lowering the carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout the day.
The aim of this study is to examine, under free living conditions and using typical dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal glycemia when compared to consuming a low-fat breakfast (per the current diabetes guidelines).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia, Okanagan.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physician-diagnosed Type 2 Diabetes (>6 months)
Exclusion Criteria:
- Exogenous Insulin
- A1c > 9%
- Cardiovascular, liver, or renal other disease
- Breakfast and meal skippers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Carbohydrate Breakfast
Breakfast composition containing <10% carbohydrate, 75% fat, 15% protein Matched calories
|
A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein.
Matched for calories to the active comparator arm.
A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein.
Matched for calories to the experimental arm.
Other Names:
|
Active Comparator: Guidelines Breakfast
Breakfast composition containing 55% carbohydrate, 30% fat, 15% protein Matched calories
|
A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein.
Matched for calories to the active comparator arm.
A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein.
Matched for calories to the experimental arm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incremental area under the glucose curve (continuous glucose monitor)
Time Frame: 24 hour (one day)
|
24 hour (one day)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Blod Glucose (continuous glucose monitor)
Time Frame: 24 hours (one day)
|
24 hours (one day)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycemic Variability (continuous glucose monitor)
Time Frame: 24 hours (one day)
|
24 hours (one day)
|
Satiety VAS 100
Time Frame: Before and after meals (one day)
|
Before and after meals (one day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan P Little, PhD, UBC Okanagan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
November 29, 2016
First Submitted That Met QC Criteria
November 30, 2016
First Posted (Estimate)
December 5, 2016
Study Record Updates
Last Update Posted (Actual)
October 13, 2017
Last Update Submitted That Met QC Criteria
October 12, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16--00377
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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