CompletedPhase 4ACTRN12606000432516

Carbohydrate Distribution

A randomized crossover trial to investigate the effect of the distribution of carbohydrates over the day on postprandial glucose excursions in individuals with type 2 diabetes using continuous glucose monitoring for a 72 hour period.


Sponsor

Commonwealth Scientific Industrial Research Organisation, Human Nutrition

Enrollment

24 participants

Start Date

Mar 6, 2006

Study Type

Interventional

Conditions

Summary

The overall aim of this proposal is to demonstrate that blood sugar elevations are minimized through an even consumption of carbohydrates throughout the day. The study aims to clinically evaluate using an energy balanced diet, the effects of an even distribution of carbohydrate across the day in comparison with an uneven distribution on blood sugar elevations and the subsequent degree of hunger. Evaluation will primarily be based on continuous glucose monitoring using a Minimed continuous glucose monitoring system (CGMS) to provide a very detailed picture of the blood glucose profile.


Eligibility

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

Plain Language Summary

Simplified for easier understanding

This study examines how the timing and distribution of carbohydrate intake throughout the day affects blood sugar control in people with type 2 diabetes. Adults ages 30 to 75 with type 2 diabetes and an HbA1c above 6.5% follow specific meal plans for 4 weeks while researchers monitor blood sugar levels.

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.

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Interventions

The trial will consist of four treatments with 40% of the total energy from carbohydrate. Treatment 1: Carbohydrates evenly distributed throughout the day. Treatment 2: Carbohydrates (~ 64%) loade

The trial will consist of four treatments with 40% of the total energy from carbohydrate. Treatment 1: Carbohydrates evenly distributed throughout the day. Treatment 2: Carbohydrates (~ 64%) loaded at breakfast. Treatment 3: Carbohydrates (~ 62%) loaded at lunch. Treatment 4: Carbohydrates (~ 62%) loaded at dinner. In the treatment 1, the carbohydrates will be evenly distributed across the day while the energy distribution for breakfast, lunch and dinner will be approximately 25%, 25% and 50% of total energy for the day which reflects what is commonly observed in Australia. The remaining three treatments (2,3&4 will contain a meal which is “loaded” with carbohydrates i.e. the majority of carbohydrates (~ 63%) consumed for the day are consumed in that meal. To enable this to occur, the energy level of the “loaded” breakfast and lunch meals will be increased by ~ 11% and the corresponding remaining meals reduced by ~ 6% relative to treatment 1 & 4. Participants will be allocated the four treatments in a randomised order. Each 24 hour treatment will be repeated on three consecutive days (72 hours). The CGMS (Continuous Glucose Monitoring system) sensor will be inserted on Monday afternoon. Participants will be free to consume food of their choice for the remained of the day and asked to fast from 8pm that evening. The following day they will commence a given treatment for 72 hours. They will then return to the clinic on Friday morning to have the CGMS sensor removed and the data downloaded to a computer. All food and dietary advice will be provided to aid compliance. This process will complete one treatment. The following Monday they will return to the clinic and the routine repeated. The study should be completed in four consecutive weeks.


Locations(1)

Australia

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ACTRN12606000432516