Carbohydrate Distributio

Phase 4

Completed

• Conditions: Type 2 diabetics with HbA1c greater than 6.5mmol/L; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12606000432516
• Lead Sponsor: Commonwealth Scientific Industrial Research Organisation, Human Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Diagnosed with Type 2 Diabetes and have HAb1C greater than 6.5% (this will be tested)• Not have type 1 diabetes• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent• No abnormality of clinical significance on medical history• If female, not pregnant or breast feeding.

Exclusion Criteria

Unable to maintain current supplements or drug use at a stable dose for the 4 week period. (We will accept volunteers taking metformin, but exclude those taking appetite suppressants). • Have a malignancy, or a 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data from the CGMS (Continuous Glucose Monitoring System)[Continuously monitored and will be downloaded and analyzed. This is an acute study running for 72 hours. An average blood glucose value will be automatically recorded every 5 minutes while wearing the monitor.]

Secondary Outcome Measures

Name	Time	Method
1. Body height and mass. Body height will be measured using a stadiometer (SECA, Hamburg, Germany) and body mass will be measured using calibrated electronic digital scales (Mercury, AMZ 14, Tokyo, Japan). [This will be measured at the beginning and end of each treatment.];2.Weighed food records and time of eating episodes.[This will be recorded for the 72hour duration of each treatment.];3.VAS (Visual Analogue Scale)degree of hunger questionnaire: Participants will complete a Visual Analogue Scale degree of hunger questionnaire each hour the volunteer is awake. [This will be completed each waking hour on each treatment.];4.Blood measurements. Fasting plasma will be collected and sent to the Institute of Medical and Veterinary Science (IMVS) for analysis of HbA1c by high-performance liquid chromatography.[This will be measured at screening only.]