Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00124553




Registration number
NCT00124553
Ethics application status
Date submitted
27/07/2005
Date registered
28/07/2005
Date last updated
28/03/2007

Titles & IDs
Public title
LOADD (Lifestyle Over and Above Drugs in Diabetes) Study
Scientific title
The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease
Secondary ID [1] 0 0
ENCDR_1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Intensive dietary advice

Behaviour: Intensive dietary advice
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Body mass index (BMI)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Glycated Haemoglobin (HbA1c)
Timepoint [2] 0 0
Primary outcome [3] 0 0
Triglycerides
Timepoint [3] 0 0
Primary outcome [4] 0 0
Dietary intake as measured by 3-day weighed diet records
Timepoint [4] 0 0
Primary outcome [5] 0 0
All measures to be compared at end of study (6 months)
Timepoint [5] 0 0
Secondary outcome [1] 0 0
Blood pressure
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Weight
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Waist circumference
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Total cholesterol and lipid subfractions (LDL, HDL)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Fasting insulin
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Lipoproteins A + B
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Inflammatory markers
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Urinary albumin:creatinine ratio
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Quality of life
Timepoint [9] 0 0
Secondary outcome [10] 0 0
All measures to be compared at end of study (6 months)
Timepoint [10] 0 0

Eligibility
Key inclusion criteria
- Type 2 diabetes

- Resident in Dunedin

- Aged <70 years at the time of invitation to participate

- Most recent HbA1c level within the last 12 months = 7%

- Currently prescribed oral tablets or insulin or both for glycaemic control AND three
of the following: *Any pre-existing cardiovascular disease defined as a past history
of myocardial infarction, angina, peripheral vascular disease, cerebrovascular
accident, transient ischaemic attack; *Currently prescribed antihypertensive
medication; *Currently prescribed lipid modifying medication; *Body mass index =25
Minimum age
No limit
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Terminal illness

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2008
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Other
Name
Edgar National Centre for Diabetes Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Otago
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes
(T2DM). More recently, this aspect of treatment has received less attention as drug therapy
aimed not only to lower glucose, but also to treat raised blood pressure and blood fats
(including cholesterol) has been more widespread. While there is evidence to suggest that
blood pressure and blood fat levels have improved, overall diabetes control has not and
people with diabetes appear to be becoming progressively more overweight, following trends in
the general population. The proposed study involves a randomised controlled trial in which
people with T2DM continuing with their regular drug treatment and surveillance, will be
randomly allocated to additionally receive intensive advice regarding diet or remain on their
usual treatment in this regard. The results will be judged principally in terms of body
weight, waist circumference, blood pressure, blood glucose control and blood fats.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00124553
Trial related presentations / publications
Mann JI, De Leeuw I, Hermansen K, Karamanos B, Karlstrom B, Katsilambros N, Riccardi G, Rivellese AA, Rizkalla S, Slama G, Toeller M, Uusitupa M, Vessby B; Diabetes and Nutrition Study Group (DNSG) of the European Association. Evidence-based nutritional approaches to the treatment and prevention of diabetes mellitus. Nutr Metab Cardiovasc Dis. 2004 Dec;14(6):373-94. doi: 10.1016/s0939-4753(04)80028-0. No abstract available.
New Zealand Guidelines Group. Assessment and Management of Cardiovascular Risk. December, 2003. Wellington, NZ. http://www.nzgg.org.nz. ISBN (print) 0-476-00091-2
New Zealand Guidelines Group. Management of Type 2 Diabetes. Wellington, NZ. December, 2003. http://www.nzgg.org.nz. ISBN (print): 0-476-00092-0
Public notes

Contacts
Principal investigator
Name 0 0
Jim I Mann, FRACP
Address 0 0
Edgar National Centre for Diabetes Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chris S Booker, BSc(Hons)
Address 0 0
Country 0 0
Phone 0 0
64-3-474-7775
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00124553