Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000206325
Ethics application status
Approved
Date submitted
11/04/2008
Date registered
17/04/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
2008 weight loss diets and resistance exercise training in type 2 diabetes study
Scientific title
A randomised study to evaluate High protein diets and resistance exercise training in type 2 diabetes study 2008
Secondary ID [1] 526 0
LZ46a issued by the Commonwealth Scientific and Industrial Research Organisation
Universal Trial Number (UTN)
Trial acronym
PE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 2862 0
Type 2 Diabetes 3059 0
Condition category
Condition code
Diet and Nutrition 3190 3190 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
16 week low fat (20% of energy) weight loss diet intervention of either high carbohydrate (55%) or high protein (35%) dietary composition. 3 of 5 groups will also participate in a whole body moderate intensity resistance exercise training program. Training sessions of 30 minutes duration held 3 times per week for 16 weeks.
Intervention code [1] 2592 0
Lifestyle
Comparator / control treatment
16 week high carbohydrate (55% of total energy) weight loss diet with and without an exercise program. Training sessions of 30 minutes duration held 3 times per week for 16 weeks.
Control group
Active

Outcomes
Primary outcome [1] 3878 0
Whole Body Composition by DEXA (dual energy x-ray absorptiometry) scan.
Timepoint [1] 3878 0
Week 0 (baseline) and Week 16.
Primary outcome [2] 4077 0
Glycaemic Control (Haemoglobin A1C (HBA1c), Glucose, Insulin from fasting venous blood sample)
Timepoint [2] 4077 0
Week 0 (baseline) and Week 16.
Secondary outcome [1] 6872 0
Cardiovascular Disease Risk (Blood Lipid Profile, Blood Pressure, Abdominal fat/waist circumference)
Timepoint [1] 6872 0
Week 0 (baseline) and Week 16.

Eligibility
Key inclusion criteria
•Male or female
•Age between 18-65 years
•BMI (body mass index) not greater than 40 or less than 27 (calculated for the volunteers by the research staff based on weight (kg) divided by height (m) squared)
•Have type 2 diabetes (HbA1c < 7.0% 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
•BMI(body mass index) greater than 40 or less than 27
•Not have type 2 diabetes (HbA1c < 7.0% or not previously diagnosed and controlled with medication)
•Lactose Intolerant
•Taking Insulin medication
•Have been previously diagnosed with proteinuria, a malignancy, or metabolic disease such as liver, kidney, respiratory, gastrointestinal disease or stroke, or are pregnant or lactating
•Have been previously diagnosed with cardiac disease, including myocardial ischemia or major heart rhythm abnormalities.
•Have high uncontrolled hypertension (resting recumbent BP >160/100 mmHg)
•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 (> 5 STD drinks/day)
•Volunteer unable to cease 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
•Widely fluctuating exercise patterns
•Currently on a weight reducing diet
•Unwilling to be randomized to either experimental group
•Extended absences due to travel or other commitments
•Unable to comprehend or cope with study requirements
•Unable to eat pork and ham on 4 occasions per week
•Unwilling to be randomised to a non-exercise arm

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are screened for inclusion and exclusion criteria and once deemed eligible are randomly allocated into one of 5 lifestyle intervention groups. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using computer software "Clinstat"
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 587 0
5000

Funding & Sponsors
Funding source category [1] 3115 0
Commercial sector/Industry
Name [1] 3115 0
Pork Cooperative Research Centre
Country [1] 3115 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
Address
Gate 13
Kintore Ave
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 2944 0
None
Name [1] 2944 0
Address [1] 2944 0
Country [1] 2944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5092 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 5092 0
Gate 13
Kintore Ave
Adelaide SA 5000
Ethics committee country [1] 5092 0
Australia
Date submitted for ethics approval [1] 5092 0
Approval date [1] 5092 0
14/12/2007
Ethics approval number [1] 5092 0
07/34
Ethics committee name [2] 5275 0
CSIRO Human Research Ethics Committee
Ethics committee address [2] 5275 0
Gate 13
Kintore Ave
Adelaide SA 5000
Ethics committee country [2] 5275 0
Australia
Date submitted for ethics approval [2] 5275 0
Approval date [2] 5275 0
14/12/2007
Ethics approval number [2] 5275 0
07/34

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

Contacts
Principal investigator
Name 28395 0
Address 28395 0
Country 28395 0
Phone 28395 0
Fax 28395 0
Email 28395 0
Contact person for public queries
Name 11552 0
Anne McGuffin
Address 11552 0
CSIRO Human Nutrition
Gate 13
Kintore Ave
Adelaide SA 5000
Country 11552 0
Australia
Phone 11552 0
+61 83038988
Fax 11552 0
+61 83038899
Email 11552 0
anne.mcguffin@csiro.au
Contact person for scientific queries
Name 2480 0
Dr Grant Brinkworth
Address 2480 0
CSIRO Human Nutrition
Gate 13
Kintore Ave
Adelaide SA 5000
Country 2480 0
Australia
Phone 2480 0
+61 83038830
Fax 2480 0
+61 83038899
Email 2480 0
grant.brinkworth@csiro.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIWeight loss on a structured hypocaloric diet with or without exercise improves emotional distress and quality of life in overweight and obese patients with type 2 diabetes2013https://doi.org/10.1111/jdi.12120
N.B. These documents automatically identified may not have been verified by the study sponsor.