A randomised crossover trial to investigate the effect of 2 different meals on diurnal blood glucose excursion

A randomised crossover trial to investigate the effect of a high carbohydrate versus a low carbohydrate breakfast on diurnal blood glucose excursion in Type 2 Diabetics.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000331235

Enrollment

Registered

2009-05-22

Start date

2009-05-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Currently fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) are used to assess diabetes control. However high peak blood sugar levels after meals probably contribute more to the complications of diabetes than high average levels. There is very little known about the effects of meal composition and carbohydrate distribution on overall blood sugar control. This study will contribute to our understanding of the role of diet in the management of type 2 diabetes and help in the development of evidence based dietary guidelines regarding carbohydrate distribution. To investigate the effect of three identical meals on diurnal blood glucose excursion,tretment 1,breakfast lunch and dinner. To explore the effect of withholding carbohydrates at first meal after a prolonged (overnight) fast on the impact of carbohydrate ingestion at lunch time,treatment 2,breakfast lunch and dinner.Hence there are 2 arms to the study each diet is investigated for one full day.A gastric emptying breath test is performed on the first day in both weeks. To determine the rate of gastric emptying when comparing a standard lunch following either a carbohydrate containing breakfast or a breakfast with no carbohydrate.

Interventions

Treatment 1 will contain 21% protein,28% fat and 51% carbohydrate this treatment will consist of 3 sandwich meals for breakfast lunch and dinner.Treatment 2 will contain 26% protein,40% fat and 34% carbohydrate,this treatment will consist of an omelette breakfast and a sandwich meal for lunch and dinner.At crossover there will be 5 days washout..Each treatment is one day.Treatment 1 and 2 are both a three meal a day treatment scheme.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

Weight stable,diagnosed with Type 2 diabetes,HbA1c, 7 for half the sample and HbA1c .8 for the other half of the sample.Treated with diet or stable on oral therapy for at least 3 months.No abnormality of clinical significance on medical history.Participants must understand the procedures involved and agree to participate in the study by giving full informed written consent

Exclusion criteria

Type 1 diabetes or insulin treated Type 2 diabetes.Have a malignancy or history of metabolic disease such as liver kidney or gastrointestinal disease.Inability to prepare meals or meet diet requirements,Unable to comprehend or cope with study requirements.

Outcome results