RecruitingACTRN12609000331235

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.

Sponsor

Commonwealth Scientific Industrial Research Organisation

Enrollment

40 participants

Start Date

May 4, 2009

Study Type

Interventional

Conditions

People with Type 2 diabetes ,20 peoplewith Glycated Haemaglobin (HbA1c)less than 7.0mmol/L and 20 people with HbA1c greater than 8 mmol/L

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.

Eligibility

Sex: Both males and femalesMin Age: 30 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how different meal plans affect blood sugar levels throughout the day in people with Type 2 diabetes. Researchers want to understand whether skipping carbohydrates at breakfast changes how the body handles carbohydrates at lunch. This could help develop better dietary guidelines for people managing their diabetes with food choices alone or with medication. You may be eligible if: - You are between 30 and 75 years old - You have been diagnosed with Type 2 diabetes - Your diabetes is managed with diet alone or with stable oral medications (unchanged for at least 3 months) - Your weight has been stable You may NOT be eligible if: - You have Type 1 diabetes or use insulin - You have liver, kidney, or significant gastrointestinal disease - You have a history of cancer or other metabolic disease - You are unable to prepare meals or follow the dietary requirements Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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% c

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.

Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609000331235