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Trial registered on ANZCTR


Registration number
ACTRN12614000220662
Ethics application status
Approved
Date submitted
24/02/2014
Date registered
3/03/2014
Date last updated
3/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Intermittent fasting for diabetes
Scientific title
For obese adult New Zealanders who have type 2 diabetes treated using insulin will a 12 week intermittent fasting diet compared with usual treatment (portion control diet) taught as group-based education be a safe and effective way to lose weight. A feasibility study.
Secondary ID [1] 284155 0
Nil
Universal Trial Number (UTN)
U1111-1152-7314
Trial acronym
IFOOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 291241 0
Type 2 Diabetes (insulin treated) 291242 0
Condition category
Condition code
Diet and Nutrition 291584 291584 0 0
Obesity
Metabolic and Endocrine 291585 291585 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week group based education. Three group education sessions (1 hour) every 4 weeks, followed by final one-to-one interview at week 12. Group sessions will cover motivation, hypo / hyperglycaemia management, blood sugar pattern management, low fat / high fibre food choices, and dietary choices for fasting days. There will be maximum of 10 participants per group (not including support person) - 2 x 10 participant groups will be run. The final one-to-one interview (45 minutes) at week 12 will include final data collection point (anthropometric and biochemical measurements) and future requirements for weight reduction interventions.
Intervention group - Healthy eating + Intermittent fasting diet. 2 days out of 7 consumption limited to 500-600kcal daily; 5 days of out 7 consumption advised low fat, regular high fibre carbohydrate usual portion sizes. Participants will complete a daily blood glucose diary which includes a weekly fasting-adherence diary. Three two day food diaries will be completed during the study. Phone call interviews will be used fortnightly, between group sessions to check blood sugar management and reminders to complete food diaries.
Intervention code [1] 288848 0
Treatment: Other
Intervention code [2] 288869 0
Lifestyle
Comparator / control treatment
12 week group based education. Three group education sessions (1 hour) every 4 weeks, followed by final one-to-one interview at week 12. Group sessions will cover motivation, hypo / hyperglycaemia management, blood sugar pattern management, low fat / high fibre food choices, and portion control to meet dietary guidelines for those with dibates. There will be maximum of 10 participants per group (not including support person) - 2 x 10 participant groups will be run. The final one-to-one interview (45 minutes) at week 12 will include final data collection point (anthropometric and biochemical measurements) and future requirements for weight reduction interventions.
Control group - Healthy eating +Portion control diet. 7 days out of 7 low fat, regular high fibre carbohydrate with portion sizes and frequencies altered to meet current NZ Healthy eating recommendations for adults with diabetes. Three two day food diaries will be completed during the study. Phone call interviews will be used fortnightly, between group sessions to check blood sugar management and reminders to complete food diaries.
Control group
Active

Outcomes
Primary outcome [1] 291536 0
Weight change - % and actual kg weight change between week 0 and week 12.
Timepoint [1] 291536 0
12 weeks after intervention commenced.
Secondary outcome [1] 306994 0
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
Timepoint [1] 306994 0
base line and 12 weeks after study commenced.
Secondary outcome [2] 306995 0
Change in long term measure of glycaemic control using serum HbA1c (mmol/mol)
Timepoint [2] 306995 0
base line and 12 weeks after study commenced.
Secondary outcome [3] 306996 0
Cardiovascular disease risk measures (waist: hip ratio, blood pressure, serum lipids)
Timepoint [3] 306996 0
baseline and 12 weeks after study commenced.
Secondary outcome [4] 306997 0
dietary acceptability as established using dietary acceptability questionnaire
Timepoint [4] 306997 0
12 weeks after study commenced.

Eligibility
Key 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.
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Candidates identified by Diabetes Service staff, or self nomination. Contact details collected by Diabetes Service Staff. Candidates sent screening form be posted back to Research Dietitian. Screening form indicates participant meets criteria. Those eligible are given the opportunity to come to an information meeting. Consent form and hypoglycaemia awareness questionnaire posted out by Research Dietitian - to be returned to Research Dietitian. Screening form indicates participant does not meet inclusion criteria - standard letter sent to inform participant. Consent form and results of hypoglycaemia awareness questionnaire indicate participant meets inclusion criteria. Participants randomised in to two groups (healthy eating + intermittent fasting or healthy eating + portion control). Allocation to treatment groups will be concealed using sealed opaque envelopes containing participant numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of allocation will be done using simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For this feasibility study a group of participants who represent the general T2DM population under the care of Waitemata DHB Diabetes Services will be recruited. Sample size and effect size calculations were not undertaken as there are no similar studies on this type of dietary intervention for Type 2 Diabetics on insulin. Based on the population treated at the Waitemata DHB Diabetes Centre and predicted enrolment rates in the study, forty participants will be enrolled. As this is a feasibility study there will be no specific sampling of population groups such as Maori. The data will be performed using SPSS software. Primary analysis: Weight (kg) will be presented as mean and standard deviation at baseline and week 12 for each treatment arm. Secondary analysis: Glycaemic control, cardiovascular risk factors dietary and acceptability will be presented as mean and standard deviation at baseline and week 12 for each treatment arm. Macronutrient intake over three days will be presented as mean and standard deviation. It is anticipated that data will be normally distributed and differences between treatment arms will analysed using a two sample t-test and correlation analysis using Pearson’s correlation coefficient

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5850 0
New Zealand
State/province [1] 5850 0
Auckland

Funding & Sponsors
Funding source category [1] 288780 0
Hospital
Name [1] 288780 0
Diabetes Service
North Shore Hospital
Waitemata District Health Board
Country [1] 288780 0
New Zealand
Primary sponsor type
Hospital
Name
Diabetes Service, North Shore Hospital
Address
North Shore Hospital
Shakespeare Road
Takapuna
Private Bag 93503
Takapuna, North Shore, 0740
Country
New Zealand
Secondary sponsor category [1] 287478 0
None
Name [1] 287478 0
Address [1] 287478 0
Country [1] 287478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290623 0
Health and Disability Commission Ethics Committees
Ethics committee address [1] 290623 0
Ministry of Health
C/- Medsafe, Leve 6, Deloitte House
10 Brandon Street
Po Box 5013
Wellington
6011
Ethics committee country [1] 290623 0
New Zealand
Date submitted for ethics approval [1] 290623 0
Approval date [1] 290623 0
18/02/2014
Ethics approval number [1] 290623 0
14/NTA/11

Summary
Brief summary
Diabetes is one of the most common chronic conditions in New Zealanders. Type 2 Diabetes is the most common type of diabetes and is a cause of considerable ill health and premature death. Weight loss can improve blood sugar control and heart health which can reduce complications of diabetes. One problem is helping people keep to dietary changes that help long term weight loss. This means that health professionals need to investigate new diets and make sure that they are safe for people with diabetes. One new diet is the “intermittent fasting diet”. This diet has people eat very little on two days a week, and a normal healthy diet on the other five days a week. Initial research shows that this type of diet may be easier to stick to and result in better insulin sensitivity than traditional diets. There has been no research on whether this type of diet is safe for people who have type 2 diabetes and are treated using insulin. This feasibility study will help tell us if this is an effective way to lose weight, and a safe diet for people with diabetes on insulin. Forty people who attend the Diabetes Centre at Waitemata DHB will be recruited for a 12 week intervention study. They will be randomly put in to two groups. One group will follow a healthy eating plus intermittent fasting diet three “meals”for two days a week, and five days a week will be a low fat, high fibre carbohydrate healthy eating plan with participants usual portion sizes. The other group will follow a healthy eating plus portion control eating plan based on Diabetes NZ dietary recommendations. Dietary information, medication dose adjustment and blood glucose patterns will be taught at a monthly group education and support programme. The hypothesis is that following an intermittent fasting diet for weight reduction is a safe and effective weight reduction strategy when compared to current standard practice of healthy eating portion controlled dietary advice.If it is safe and effective diet for people with diabetes on insulin then it could have direct impact on improving quality of life and reducing healthcare burdens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46482 0
Mrs Katrina Pace
Address 46482 0
Dietitian
Diabetes Service, Waitemata DHB
North Shore Hospital
Shakespeare Road
Takapuna
North Shore 0740
Country 46482 0
New Zealand
Phone 46482 0
+6494861491 ext 2505
Fax 46482 0
Email 46482 0
[email protected]
Contact person for public queries
Name 46483 0
Katrina Pace
Address 46483 0
Dietitian
Diabetes Service, Waitemata DHB
North Shore Hospital
Shakespeare Road
Takapuna
North Shore 0740
Country 46483 0
New Zealand
Phone 46483 0
+6494861491 ext 2505
Fax 46483 0
Email 46483 0
[email protected]
Contact person for scientific queries
Name 46484 0
Katrina Pace
Address 46484 0
Dietitian
Diabetes Service, Waitemata DHB
North Shore Hospital
Shakespeare Road
Takapuna
North Shore 0740
Country 46484 0
New Zealand
Phone 46484 0
+6494861491 ext 2505
Fax 46484 0
Email 46484 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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