Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03689608




Registration number
NCT03689608
Ethics application status
Date submitted
26/09/2018
Date registered
28/09/2018
Date last updated
11/01/2022

Titles & IDs
Public title
Daily vs Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk (DIRECT)
Scientific title
Daily vs Intermittent Restriction of Energy: Randomised Controlled Trial to Reduce Diabetes Risk (DIRECT)
Secondary ID [1] 0 0
R20180319
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals at Risk of Developing Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intermittent Fasting (IF)
Other interventions - Daily Restriction (DR)
Other interventions - standard care (SC)

Experimental: Intermittent Fasting (IF) - 3 days fasting per week

Experimental: Daily Restriction (DR) - daily energy restriction

Other: standard care (SC) - usual care


Other interventions: Intermittent Fasting (IF)
Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

Other interventions: Daily Restriction (DR)
Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

Other interventions: standard care (SC)
Participants will receive current practice guidelines in a static information format, will not take part in any counselling or receive meal replacements.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Postprandial glucose AUC
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
2 months, 6 months, 18 months
Secondary outcome [2] 0 0
Postprandial glucose
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Body weight
Timepoint [3] 0 0
2 months, 6 months, 18 months
Secondary outcome [4] 0 0
Body composition
Timepoint [4] 0 0
6 months, 18 months
Secondary outcome [5] 0 0
Waist and hip circumference
Timepoint [5] 0 0
2 months, 6 months, 18 months
Secondary outcome [6] 0 0
Blood lipids
Timepoint [6] 0 0
2 months, 6 months, 18 months
Secondary outcome [7] 0 0
Dietary intake
Timepoint [7] 0 0
2 months, 6 months, 18 months
Secondary outcome [8] 0 0
Blood pressure
Timepoint [8] 0 0
2 months, 6 months, 18 months
Secondary outcome [9] 0 0
Changes in physical Activity assessed by accelerometer
Timepoint [9] 0 0
2 months, 6 months, 18 months
Secondary outcome [10] 0 0
Fasting glucose
Timepoint [10] 0 0
2 months, 6 months, 18 months
Secondary outcome [11] 0 0
Fasting insulin
Timepoint [11] 0 0
2 months, 6 months, 18 months
Secondary outcome [12] 0 0
Fasting non-esterified fatty acids (NEFA)
Timepoint [12] 0 0
2 months, 6 months, 18 months
Secondary outcome [13] 0 0
Fasting triglyceride
Timepoint [13] 0 0
2 months, 6 months, 18 months
Secondary outcome [14] 0 0
Postprandial insulin
Timepoint [14] 0 0
6 months, 18 months
Secondary outcome [15] 0 0
Postprandial non-esterified fatty acids (NEFA)
Timepoint [15] 0 0
6 months, 18 months
Secondary outcome [16] 0 0
Postprandial triglyceride
Timepoint [16] 0 0
6 months, 18 months

Eligibility
Key inclusion criteria
* weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry)
* score 12 or greater on the AUSDRISK calculator
* HbA1c <48 mmol/mol (measured at screening)
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Personal history/diagnosis (self-reported) of diabetes (type 1 or 2), major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders), gastrointestinal disorders, haematological disorders (i.e. thalassemia, iron-deficiency anaemia) insomnia, or any other medical condition, deemed unstable by the study physician.
* Participants currently taking the following medications will be excluded from participating: any medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, Glucagon-like peptide-1 GLP-1 analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone) or SSRI's will not be excluded.
* weight change in past 3 months (> 5% screening weight)
* uncontrolled asthma, current fever, upper respiratory infections
* individuals who regularly perform high intensity exercise (>2 week)
* current intake of > 140g alcohol/week
* current smokers of cigarettes/cigars/marijuana/e-cigarettes/vaporisers
* current intake of any recreational drugs
* regular blood donor
* unable to comprehend study protocol due to English language or cognitive difficulties

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2021
Sample size
Target
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
Address 0 0
The University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/08/NCT03689608/SAP_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03689608