Continuous glucose monitoring system used to establish medication management protocol for the safe use of a 2-day intermittent energy restriction (5:2 diet) in type 2 diabetes mellitus.

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Obesity; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12617000512325
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-07
• Study Completion: 2018-09-04
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Aged >18yrs
Medication controlled Type 2 Diabetes (sulphonylureas or insulin)
Experiencing hypoglycaemic events during the usual diet
BMI >27kg/m2

Exclusion Criteria

Women who are pregnant or breast feeding or wish to become pregnant.
Weight loss surgery, ongoing weight loss studies or weight loss of 4.5kg or more in past 3mths, IER diet in the last 3mths.
Blood pressure >160/100 mm Hg
Drinking >2 standard drinks per day and unable/unwilling to stop
Eating out more than once a week and not able/willing to decrease for the duration of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of hypoglycaemic events (<4mmol/L). The outcome is assessed via data from the continuous glucose monitoring system. [Continuous blood glucose monitoring results after 2 weeks on normal diet, then 2 weeks on IER diet with allocated protocol.];Number of hyperglycaemic events (>10mmol/L). The outcome is assessed via data from the continuous glucose monitoring system. [Continuous blood glucose monitoring results after 2 weeks on normal diet, then 2 weeks on IER diet with allocated protocol.]

Secondary Outcome Measures

Name	Time	Method
/A [N/A]