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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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ENCDR_1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Body mass index (BMI)
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Glycated Haemoglobin (HbA1c)
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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Triglycerides
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Assessment method [3]
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Timepoint [3]
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Primary outcome [4]
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Dietary intake as measured by 3-day weighed diet records
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Assessment method [4]
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Timepoint [4]
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Primary outcome [5]
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All measures to be compared at end of study (6 months)
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [1]
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Blood pressure
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Weight
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Waist circumference
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Total cholesterol and lipid subfractions (LDL, HDL)
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Fasting insulin
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Lipoproteins A + B
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Inflammatory markers
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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Urinary albumin:creatinine ratio
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [9]
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Quality of life
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Assessment method [9]
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Timepoint [9]
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Secondary outcome [10]
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All measures to be compared at end of study (6 months)
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Assessment method [10]
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Timepoint [10]
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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
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Minimum age
No limit
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Terminal illness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2008
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Primary sponsor type
Other
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Name
Edgar National Centre for Diabetes Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Otago
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00124553
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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 Coppell KJ, Kataoka M, Williams SM, Chisholm AW, Vorgers SM, Mann JI. Nutritional intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised controlled trial. BMJ. 2010 Jul 20;341:c3337. doi: 10.1136/bmj.c3337.
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Public notes
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Contacts
Principal investigator
Name
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Jim I Mann, FRACP
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Address
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Edgar National Centre for Diabetes Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Chris S Booker, BSc(Hons)
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Address
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Country
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Phone
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64-3-474-7775
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Fax
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Email
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[email protected]
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00124553
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