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OpenTrials
Completed

NCT Number: NCT02982330

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

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).

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Key information

Conditions

Type2 Diabetes

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Carbohydrate Breakfast

Behavioral

A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.

Guidelines Breakfast

Behavioral

A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.

Other names: Low-fat Breakfast

Primary outcomes

  1. Incremental area under the glucose curve (continuous glucose monitor)

    Time frame: 24 hour (one day)

Secondary outcomes

  1. Mean Blod Glucose (continuous glucose monitor)

    Time frame: 24 hours (one day)

Other outcomes

  1. Glycemic Variability (continuous glucose monitor)

    Time frame: 24 hours (one day)

  2. Satiety VAS 100

    Time frame: Before and after meals (one day)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2016
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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