Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000402640
Ethics application status
Not yet submitted
Date submitted
7/03/2014
Date registered
14/04/2014
Date last updated
14/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of 5:2 fasting dietary plan in obese patients with type 2 diabetes: A pilot study
Scientific title
A randomised parallel pilot study to assess the tolerability and application of a 5:2 fasting dietary plan in obese patients with type 2 diabetes
Secondary ID [1] 284217 0
Nil
Universal Trial Number (UTN)
U1111-1148-1638
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
 291326 0
Type 2 Diabetes 291327 0
Condition category
Condition code
Metabolic and Endocrine 291683 291683 0 0
Diabetes
Diet and Nutrition 291722 291722 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 week dietary intervention where participants fast (reduction to 25% of normal calorie intake) on 2 days each week. The group will be randomised so that half fast on consecutive days each and the other half may chose any 2 days to fast within each 7 day period. The participants will be provided with example meal plans for fasting days but no food is provided in this study. Diet diaries are to be used at the start and end of the study period. A pre-defined medication adjustment protocol will be used to adjust glucose lowering medications on fasting days.
Intervention code [1] 288918 0
Treatment: Other
Intervention code [2] 288952 0
Lifestyle
Comparator / control treatment
This is an active controlled study with 2 arms; one arm will fast on consecutive days within a week, whilst the other arm will fast on any 2 days within a 7 day period. The participants will be provided with example meal plans for fasting days but no food is provided in this study. Diet diaries are to be used at the start and end of the study period
Control group
Active

Outcomes
Primary outcome [1] 291624 0
Effect on glucose profile assessed via continuous glucose monitoring (CGMS)
Timepoint [1] 291624 0
12 weeks
Primary outcome [2] 291625 0
Effectiveness of medication adjustment protocol on frequency of hypoglycaemia assessed through weekly contact with a research nurse. Frequency of hypoglycaemia will be recorded through regular participant use of glucose meters, and self monitoring of glucose levels when symptoms suggestive of hypoglycaemia develop.
Timepoint [2] 291625 0
12 weeks
Secondary outcome [1] 307185 0
Change in weight, waist circumference, and blood pressure between baseline readings and those at 12 weeks.
Timepoint [1] 307185 0
12 weeks
Secondary outcome [2] 307186 0
Change in HbA1c, cholesterol profile, ghrelin, leptin measured on fasting blood samples taken at baseline and 12 weeks
Timepoint [2] 307186 0
12 weeks

Eligibility
Key inclusion criteria
BMI 30 - 45 kg/m2
Type 2 diabetes treated with Metformin and/or a
Sulphonylurea and/or insulin therapy
HbA1c 64 – 86 mmol/mol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes
Known eating disorder
Recent significant weight change (> 5 kg over past 3 months)
Previous bariatric surgery
Currently pregnant or planning pregnancy within 3 months
Uncontrolled hypertension (180/100mmHg)
Significant medical condition which, in the view of study
investigators, would make recruitment in study
inappropriate.

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)
Participants will be identified from diabetes clinics at our local diabetes centre. Informed consent will be obtained, and participants will be randomly allocated (1:1) to one of the 2 previously described treatment arms. Randomisation will be performed through the use of sealed opaque envelopes prepared by one of the study investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed envelopes will be prepared by a study investigator with other investigators blinded to their contents. Half of the envelopes will contain a statement that the participant is to be allocated to consecutive days fasting, whilst the other half will contain a statement that the participant is to be allocated to non consecutive days fasting. At randomisation, each participant will select an envelope. Both participant and study investigator will be unaware of the envelopes contents prior to opening.
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
Statistical methods / analysis
We wish to confirm that the standard deviations of weight and HbA1c are as anticipated (20kg for weight and 10 mmol/mol for HbA1c based on published dietary intervention studies) and to estimate those for gut-peptide physiology variables. These standard deviations will be used to calculate sample size for a definitive randomised controlled study of this intervention. The study design has 20 participants in each group. This gives adequate degrees of freedom to determine the standard deviation of the main measurements and also will give reasonable precision to determine the tolerability of the diet with a margin of error of about plus or minus 15%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2014
Actual
Date of last participant enrolment
Anticipated
1/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5870 0
New Zealand
State/province [1] 5870 0
Wellington region

Funding & Sponsors
Funding source category [1] 288840 0
Other Collaborative groups
Name [1] 288840 0
Endocrine, diabetes and research centre
Country [1] 288840 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Endocrine, diabetes and research centre
Address
Wellington regional hospital
Riddiford Street
Newtown
Wellington 6011
Country
New Zealand
Secondary sponsor category [1] 287534 0
None
Name [1] 287534 0
Address [1] 287534 0
Country [1] 287534 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290680 0
New Zealand multiregional ethics committee
Ethics committee address [1] 290680 0
Ethics committee country [1] 290680 0
New Zealand
Date submitted for ethics approval [1] 290680 0
10/03/2014
Approval date [1] 290680 0
Ethics approval number [1] 290680 0

Summary
Brief summary
A pilot study to assess the safety and tolerability of a 5:2 diet for obese persons with type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46754 0
Dr Jeremy Krebs
Address 46754 0
Endocrine, diabetes and research centre
Wellington regional hospital
Riddiford Street
Newtown
Wellington 6011
Country 46754 0
New Zealand
Phone 46754 0
+64 048062140
Fax 46754 0
Email 46754 0
[email protected]
Contact person for public queries
Name 46755 0
Dr Richard Carroll
Address 46755 0
Endocrine, diabetes and research centre
Wellington regional hospital
Riddiford Street
Newtown
Wellington 6011
Country 46755 0
New Zealand
Phone 46755 0
+64 048062140
Fax 46755 0
Email 46755 0
[email protected]
Contact person for scientific queries
Name 46756 0
Dr Richard Carroll
Address 46756 0
Endocrine, diabetes and research centre
Wellington regional hospital
Riddiford Street
Newtown
Wellington 6011
Country 46756 0
New Zealand
Phone 46756 0
+64 048062140
Fax 46756 0
Email 46756 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial.2018https://dx.doi.org/10.1111/dme.13595
EmbaseIntermittent fasting 5:2 diet: What is the macronutrient and micronutrient intake and composition?.2020https://dx.doi.org/10.1016/j.clnu.2020.02.022
N.B. These documents automatically identified may not have been verified by the study sponsor.