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Trial registered on ANZCTR


Registration number
ACTRN12612000369820
Ethics application status
Approved
Date submitted
15/03/2012
Date registered
30/03/2012
Date last updated
14/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Role of very low carbohydrate diets for type 2 diabetes- Diabetes management
Scientific title
Long-term (2 years) effects of a very low carbohydrate, low saturated fat diet compared to a conventional high carbohydrate, low fat diet on glycemic control and cardiovascular disease risk in overweight and obese patients with type 2 diabetes.
Secondary ID [1] 280093 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 286008 0
Condition category
Condition code
Metabolic and Endocrine 286195 286195 0 0
Diabetes
Diet and Nutrition 286397 286397 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Very low carbohydrate, low saturated fat diet (N=75: 14% carbohydrate [<50 g carbohydrate/day], 28% protein, 58% fat). The overall duration of the study is 2 years (104 weeks).

The dietary pattern will be translated and consumed daily for the duration of the study in the form a dietary plan that incorporates freely available foods from the current food supply. This will include a breakfast, lunch and evening meal and snacks that will reflect the dietary composition described.
Intervention code [1] 284366 0
Lifestyle
Comparator / control treatment
High carbohydrate, low saturated fat diet (N=75: 53% carbohydrate, 17%, protein, 30% fat). The overall duration of the study is 2 years (104 weeks).

The dietary pattern will be translated and consumed daily for the duration of the study in the form a dietary plan that incorporates freely available foods from the current food supply. This will include a breakfast, lunch and evening meal and snacks that will reflect the dietary composition described.
Control group
Active

Outcomes
Primary outcome [1] 286730 0
Glycated haemoglobin measured at a certified clinical laboratory using standard assay kits.
Timepoint [1] 286730 0
Weeks 0, 24, 52 and 104
Primary outcome [2] 286851 0
flow mediated dilatation measured using ultrasound to assess the diameter change in the brachial artery in response to increased blood flow induced by 5 minutes of forearm occlusion with an inflated blood pressure cuff placed around the forearm.
Timepoint [2] 286851 0
Weeks 0, 24, 52 and 104
Secondary outcome [1] 296548 0
blood lipids measured using a clinical auto-anaylser and standard assay kits.
Timepoint [1] 296548 0
Weeks 0, 24, 52 and 104
Secondary outcome [2] 296807 0
body composition measured using dual x-ray absorptometry.
Timepoint [2] 296807 0
Weeks 0, 24, 52 and 104
Secondary outcome [3] 304161 0
Body weight measured using calibrated clinic weighting scales
Timepoint [3] 304161 0
Week 0, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 74, 78, 82, 86, 92, 96, 100, 104
Secondary outcome [4] 304162 0
Fasting plasma insulin measured using a standard Elisa Kit
Timepoint [4] 304162 0
Week 0, 24, 52 and 104
Secondary outcome [5] 304163 0
Medication changes document by medication name and dosage changes
Timepoint [5] 304163 0
Week 0, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 74, 78, 82, 86, 92, 96, 100, 104
Secondary outcome [6] 304164 0
Blood Pressure measure using automated oscillation
Timepoint [6] 304164 0
Week 0, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 74, 78, 82, 86, 92, 96, 100, 104
Secondary outcome [7] 304165 0
Glycemic variability and diurnal patterning using 3-day continuous glucose monitoring
Timepoint [7] 304165 0
Week 0, 24, 52 and 104
Secondary outcome [8] 304166 0
Plasma folate, B12 and Homocysteine, Vitamin D measured at a certified clinical laboratory using standard assay kits.
Timepoint [8] 304166 0
Week 0, 24, 52 and 104
Secondary outcome [9] 304167 0
Serum Beta crosslaps and parathyroid hormone measured at a certified clinical laboratory using standard assay kits.
Timepoint [9] 304167 0
Week 0, 24, 52 and 104
Secondary outcome [10] 304168 0
Fasting plasma creatinine measured using a clinical auto-anaylser and standard assay kits.
Timepoint [10] 304168 0
Weeks 0, 24, 52 and 104
Secondary outcome [11] 304169 0
Fasting plasma ketones measured using a clinical auto-anaylser and standard assay kits.
Timepoint [11] 304169 0
Week 0, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 74, 78, 82, 86, 92, 96, 100, 104
Secondary outcome [12] 304170 0
Inflammatory markers of human cardiovascular disease risk markers using standard multiplex assay kits
Timepoint [12] 304170 0
Weeks 0, 24, 52 and 104
Secondary outcome [13] 304171 0
Human tissue telomere length using quantitative PCR (qPCR)
Timepoint [13] 304171 0
Weeks 0, 24, 52 and 104
Secondary outcome [14] 304172 0
Plasma nitrates/nitrites measured using a clinical auto-anaylser and standard assay kits.
Timepoint [14] 304172 0
Weeks 0, 24, 52 and 104
Secondary outcome [15] 304173 0
Urinary albumin, urea, calcium and creatinine measured at a certified clinical laboratory using standard assay kits.
Timepoint [15] 304173 0
Weeks 0, 24, 52 and 104
Secondary outcome [16] 304174 0
Mood state, sleep quality, food cravings, and mental wellbeing using a series of validated assessment questionnaires.
Mood Questionnaires: Beck Depression Inventory, Spielberger Strait-trait anxiety Inventory, Profile of Mood States, Diabetes 39 – Quality of Life Questionnaire, Problem Areas in Diabetes Questionnaire, Pittsburgh Sleep Quality Index, Food Cravings Inventory, Eating Style Scale.
Timepoint [16] 304174 0
Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 74, 78, 82, 86, 92, 96, 100, 104
Secondary outcome [17] 304175 0
Physical activity measured using 7-day accelerometery and the international physical activity questionnaire (Ipaq)
Timepoint [17] 304175 0
Week 0, 24, 52 and 104
Secondary outcome [18] 304176 0
Appetite using a validated 7-day appetite history and record log
Timepoint [18] 304176 0
Week 0, 4,16, 24 and 52
Secondary outcome [19] 304177 0
Cognitive Function assessed using a series of validated paper and computer based assessments.
The list of cognitive tasks are: Odd man out reaction time, Word memory, Operation span, 2 choice reaction time, Number memory scanning, Colour stroop task, Digit symbol substitution, Word endings and Letter sets.
Timepoint [19] 304177 0
Weeks 0, 24, 52 and 104
Secondary outcome [20] 304178 0
Food intake using weighed food records and diet histories
Timepoint [20] 304178 0
Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 74, 78, 82, 86, 92, 96, 100, 104
Secondary outcome [21] 304179 0
Breathe Volatile Compounds in the exhaled breath by mass spectrometry
Timepoint [21] 304179 0
Week 0, 12 and 52

Eligibility
Key inclusion criteria
Male or female
Age between 35-65 years
Body Mass Index not greater than 40 or less than 26 Have type 2 diabetes (HbA1c 7.0-9.0% or previously diagnosed and controlled with medication)
Not have type 1 diabetes
Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent
No abnormality of clinical significance on medical history
If female,not pregnant or breast feeding
No history of coronary artery disease or cardiac (heart) abnormalities
Minimum age
35 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body Mass Index greater than 40 or less than 26
Not have type 2 diabetes
Lactose Intolerant
Have proteinuria, a malignancy, abnormal liver function, any significant endocrinopathy, or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease, cardiac (heart) abnormalities or are pregnant or lactating
Have high uncontrolled hypertension (resting recumbent blood pressure greater than 160/100 mmHg)
Have depression
Have a musculoskeletal injury, joint or peripheral vascular disease sufficient to impede exercise (such as hip arthritis, foot, ankle problems or pain)
Have severe exercise-induced asthma
History of smoking during 6 months prior to study
History of heavy alcohol consumption (more than 5 Standard drinks/day)
Volunteer unable to limit alcohol consumption for study duration
Participated in regular aerobic or resistance exercise program (greater than two 30-min sessions of moderate/vigorous aerobic exercise per week or greater than 1 moderate intensity resistance exercise session per week) during the 6 months prior to study
Currently on a weight reducing diet or have an eating disorder
Unwilling to be randomized to either experimental group
Extended absences due to travel or other commitments
Unable to comprehend or cope with study requirements

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284852 0
Government body
Name [1] 284852 0
National Health and Medical Research Council
Address [1] 284852 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 284852 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation - Food and Nutritional Sciences
Address
Gate 13
Kintore Avenue
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 283730 0
None
Name [1] 283730 0
Address [1] 283730 0
Country [1] 283730 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To evaluate, in overweight/obese patients with type 2 diabetes mellitus the chronic effects (24 months) of an energy restricted, very low carbohydrate (<50 g/day), low saturated fat (<10%) diet compared to an isocaloric high unrefined carbohydrate, low fat diet on:
Primary outcomes: glycemic control, cardiovascular disease risk factors and endothelial function
Secondary outcomes: weight loss, body composition, appetite, diet acceptance, renal/bone health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33846 0
Dr Grant Brinkworth
Address 33846 0
Commonwealth Scientific Industrial Research Organisation
Gate 13 Kintore Avenue Adelaide SA 5000
Country 33846 0
Australia
Phone 33846 0
+61 8 83038830
Fax 33846 0
Email 33846 0
grant.brinkworth@csiro.au
Contact person for public queries
Name 17093 0
Ms Anne McGuffin
Address 17093 0
Gate 13
Kintore Avenue
Adelaide SA 5000
Country 17093 0
Australia
Phone 17093 0
+61 8 83038988
Fax 17093 0
Email 17093 0
anne.mcguffin@csiro.au
Contact person for scientific queries
Name 8021 0
Dr Dr Grant Brinkworth
Address 8021 0
Gate 13
Kintore Avenue
Adelaide SA 5000
Country 8021 0
Australia
Phone 8021 0
+61 8 8303 8830
Fax 8021 0
Email 8021 0
grant.brinkworth@csiro.au

No information has been provided regarding IPD availability
Summary results
No Results