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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
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
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
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
Trial website
Trial related presentations / publications
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

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