Intermittent fasting for diabetes

Not Applicable

• Conditions: Obesity; Type 2 Diabetes (insulin treated); Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614000220662
• Lead Sponsor: Diabetes Service, North Shore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Type 2 diabetes treated using insulin (+/- oral hypoglycaemic agents). Body Mass index 30-39 kg/m2 (inclusive). Aged 35-65 years (inclusive), HbA1c 55-90 mmol/mol. Screened for hypoglycaemic awareness and frequency. Stable and well controlled other medical conditions. Willing to undertake a 12 week intervention for weight reduction.

Exclusion Criteria

Hypoglycaemic unawareness / admission to hospital in previous 12 months with diabetic ketoacidosis, hyperglycaemia, hypoglycaemia. Renal disease / chronic kidney disease. Unstable heart disease. Diagnosed eating disorder in the past. Medical condition where sudden weight loss may impact on either condition or treatment. Unstable or uncontrolled medical conditions. Pregnant or breastfeeding women. Requires translation of written or spoken English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight change - % and actual kg weight change between week 0 and week 12.[12 weeks after intervention commenced.]

Secondary Outcome Measures

Name	Time	Method
self-reported number of hypglycaemic events, as defined by blood sugar reading of less than 4mmol/L, recorded in blood sugar diary during 12 week trial, and change in hypoglycaemic awareness questionnaire results[base line and 12 weeks after study commenced.];Change in long term measure of glycaemic control using serum HbA1c (mmol/mol)[base line and 12 weeks after study commenced.];Cardiovascular disease risk measures (waist: hip ratio, blood pressure, serum lipids)[baseline and 12 weeks after study commenced.];dietary acceptability as established using dietary acceptability questionnaire [12 weeks after study commenced.]