Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982330
• Other study ID #: H16--00377
• Status: Completed
• Phase: N/A
• First received: November 29, 2016
• Last updated: October 12, 2017
• Start date: November 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Behavioral:
• Low Carbohydrate Breakfast
A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.
• Guidelines Breakfast
A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan.	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycemic Variability (continuous glucose monitor)		24 hours (one day)
Other	Satiety VAS 100		Before and after meals (one day)
Primary	Incremental area under the glucose curve (continuous glucose monitor)		24 hour (one day)
Secondary	Mean Blod Glucose (continuous glucose monitor)		24 hours (one day)