Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000416392
Ethics application status
Approved
Date submitted
13/08/2008
Date registered
25/08/2008
Date last updated
27/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary itervention in overweight adolescents with pre-diabetes
Scientific title
A randomised control trial investigating the effects of dietary protein on insulin sensitivity in overweight adolescents with clinical insulin resistance and/or pre-diabetes
Secondary ID [1] 273504 0
TGA 2008/520
Universal Trial Number (UTN)
Trial acronym
RESIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 3552 0
Clinical insulin resistance 3553 0
Condition category
Condition code
Metabolic and Endocrine 3708 3708 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants (intervention group and comparator group) will be prescribed metformin and participate in a diet and exercise program. The diet and exercise program will be the same for all participants except for the macronutrient content of the diet. The intervention diet is moderate carbohydrate and increased protein. Carbohydrate will provide 40 to 45% of energy and protien will provide 25 to 30% of energy. The energy level will be tailored on an individual basis to incorporate an energy restriction of approximately 500-1000 kilojoules (kJ)/day. Particpants will be encourage to stay on the diet for 12 months.Individual, face to face, dietary instruction will be given by a dietitian (6 consultations of 30 to 60 minutes, over 12 months) which will be supported by computer/phone support (8 contacts of 5 to 10 minutes, over 12 months) according to a pre established schedule
Intervention code [1] 3265 0
Lifestyle
Comparator / control treatment
All participants (intervention group and comparator group) will be prescribed metformin and participate in a diet and exercise program. The diet and exercise program will be the same for all participants except for the macronutrient content of the diet. The comparator goup will be high carbohydrate, low fat diet. Carbohydrate will provide 55 to 60% of energy and protien will provide 10 to 15% of energy. The energy level will be tailored on an individual basis to incorporate an energy restriction of approximately 500-1000 kJ/day.Particpants will be encourage to stay on the diet for 12 months. Individual, face to face, dietary instruction will be given by a dietitian (6 consultations, 30 to 60 minutes, over 12 months) which will be supported by computer/phone support (8 contacts of 5 to 10 minutes, over 12 months) according to a pre established schedule
Control group
Active

Outcomes
Primary outcome [1] 4612 0
10,000/square root of (fasting insulin (?U/ml) x fasting glucose (mg/dl)) x (mean 2hr insulin (?U/ml) x mean 2hr glucose (mg/dl))
Timepoint [1] 4612 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [1] 7781 0
Adiposity. Adiposity will be measured by dual energy x-ray absorptiometry and anthropometry
Timepoint [1] 7781 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [2] 319233 0
Insulin sensitivity index (OGTT) and adiposity will be measured by dual energy x-ray absorptiometry and anthropometry
Timepoint [2] 319233 0
24 months

Eligibility
Key inclusion criteria
Overweight/obese with a fasting insulin (pmol/L)/glucose (mmol/L) ratio >20 and one or more of the following: acanthosis nigricans, polycystic ovarian syndrome (PCOS), hypertension, dyslipidaemia.
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 or type 2 diabetes , contraindications to metformin therapy, secondary causes of obesity, psychiatric disturbance, significant mental illness, inability to take part in physical activity, taking metformin, weight loss medications or medications known to cause weight gain, and weight >120kg. Neither parent nor carer speaks English.

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)
Recruitment will occur through hospital referral (the Endocrinology or Weight Management Services, the Children's Hospital at Westmead (CHW), Royal Prince Alfred Hospital (RPAH) or Campbelltown Hospital(CH)), GP and paediatricians. Treatment allocation will occur centrally by minimisation with the aid of computer software, by the statistician in the Clinical Epidemiology Unit, CHW
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation will occur centrally by minimisation with the aid of computer software. To adjust for potential confounding influences participants will be randomised into dietary groups stratified by sex, age and BMI.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
20/01/2009
Date of last participant enrolment
Anticipated
1/12/2011
Actual
1/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3731 0
Charities/Societies/Foundations
Name [1] 3731 0
BUPA Foundation
Country [1] 3731 0
Australia
Funding source category [2] 3732 0
Charities/Societies/Foundations
Name [2] 3732 0
Diabetes Australia Research Trust
Country [2] 3732 0
Australia
Funding source category [3] 284291 0
Charities/Societies/Foundations
Name [3] 284291 0
The Heart Foundation
Country [3] 284291 0
Australia
Primary sponsor type
Individual
Name
Sarah Garnett
Address
Division of Research
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2001
Country
Australia
Secondary sponsor category [1] 3348 0
Individual
Name [1] 3348 0
Chris Cowell
Address [1] 3348 0
Division of Research
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2001
Country [1] 3348 0
Australia
Other collaborator category [1] 370 0
Individual
Name [1] 370 0
Louise Baur
Address [1] 370 0
Clinical School
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country [1] 370 0
Australia
Other collaborator category [2] 371 0
Individual
Name [2] 371 0
Manny Noakes
Address [2] 371 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041
Adelaide SA 5000
Country [2] 371 0
Australia
Other collaborator category [3] 372 0
Individual
Name [3] 372 0
Kate Steinbeck
Address [3] 372 0
Metabolism and Obesity Services
Royal Prince Alfred Hospital
Camperdown NSW
Country [3] 372 0
Australia
Other collaborator category [4] 373 0
Individual
Name [4] 373 0
Helen Woodhead
Address [4] 373 0
Department of Paediatrics
Campbelltown Hospital
Terry Road
Campbelltown NSW 2560
Country [4] 373 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5784 0
The Royal Alexandra Hospital for Children
Ethics committee address [1] 5784 0
Locked Bag 4001
Westmead NSW 2145
Ethics committee country [1] 5784 0
Australia
Date submitted for ethics approval [1] 5784 0
Approval date [1] 5784 0
13/06/2008
Ethics approval number [1] 5784 0
EC00130

Summary
Brief summary
Obesity in adolescents is a major public health problem in Australia and the prevalence is increasing. Along with the rise in prevalence of obesity there has been a dramatic increase in the number of adolescents with insulin resistance and/or pre-diabetes.
It is essential that insulin resistance/pre-diabetes in adolescents be targeted for early intervention. Unmanaged it is likely to progress to type 2 diabetes and early cardiovascular disease. Development of type 2 diabetes in adolescence is of particular concern as complications are common and appear early in the disease. However, there is only limited evidence to guide management of clinical insulin resistance in young people.
The aim of this study is to establish an evidence based management plan for these adolescents by undertaking a randomised control trial designed to examine the role of dietary protein in improving insulin sensitivity and metabolic profile.
Trial website
Trial related presentations / publications
Publications
1. ML Gow, N van Doorn, CR Broderick, LL Hardy, M Ho,LA Baur,CT Cowell, SP Garnett. Sustained improvements in fitness and exercise tolerance in obese adolescents: secondary data analysis from the RESIST randomized control trial. Obesity Research Clinical Practice Accepted April 2015
2. M Ho, J Halim, M Gow, N El-Haddad, T Marzulli, LA Baur, CT Cowell, SP Garnett. Vitamin B12 status in obese adolescents with clinical features of insulin resistance. Nutrients. 2014; 6:5611-8
3. SP Garnett, Gow, M Ho, LA Baur, M Noakes, HJ Woodhead, CR Broderick,K Chisholm, J Halim, J Briody, S De,K Steinbeck, S Srinivasan, GR Ambler, CT Cowell. Improved insulin sensitivity and body composition, irrespective of macronutrient intake, after a 12 month intervention in adolescents with pre-diabetes; RESIST a randomised control trial. BMC Pediatr. 2014; 14:289
4. CS Wan, LC Ward, J Halim, M Gow, M Ho, JN Briody, K Leung, CT Cowell, SP Garnett. Bioelectrical impedance analysis to estimate body composition in overweight and obese adolescents: comparison with dual-energy x-ray absorptiometry. BMC Pediatr 2014, 14:249
5. M Ho, SP Garnett, LA Baur. Childhood obesity and insulin resistance: how should it be managed? Current Treatment Options in Cardiovascular Medicine. doi: 10.1007/s11936-014-0351-0
6. M Ho, Paul Z Benitez-Aguirre, KC Donaghue, P Mitchell, LA Baur, A Jenkins, ME Craig, CT Cowell, SP Garnett. Arterial elasticity in obese adolescents with clinical features of insulin resistance. Diab Vasc Dis Res. 2015; 12:62-9
7. M Ho, M Gow, LA Baur, PZ Benitez-Aguirre, CS Tam, KC Donaghue, ME Craig, CT Cowell, SP Garnett. Effect of fat loss on arterial elasticity in obese adolescents with clinical insulin resistance: RESIST study. J Clin Endo Met. 2014 99:E1846-53
8. G Joslowski1, J Halim, J Goletzke, M Gow, M Ho, J Louie, A Buyken, C T Cowell, SP Garnett. Dietary glycaemic load, insulin load, and weight loss in obese, insulin resistant adolescents: RESIST study. Clin Nutr 2015;34:89-94.
9. M Ho, M Gow, J Halim, K Chisholm, LA Baur, M Noakes, K Steinbeck, MR Kohn, CT Cowell, SP Garnett. Effect of a prescriptive dietary intervention on psychological dimensions of eating behavior in obese adolescents Int J Behav NutrPhy Act 2013; 10:119.
10. G Joslowski, T Remer, KE Assmann, D Krupp, G Cheng, SP Garnett, et al. Animal protein intakes during early life and adolescence differ in their relation to the growth hormone-insulin-like-growth-factor axis in young adulthood. J Nutrition 2013 143: 7 1147-1154;
11. SP Garnett et al. Optimal macronutrient content of the diet for adolescents with pre-diabetes; RESIST a randomised control trial. J Clin Endo Metab. 2013 98:2116-25.
12. SP Garnett, LA Baur, M Noakes et al. Researching Effective Strategies to Improve Insulin Sensitivity in Children and Teenagers - RESIST. A randomised control trial investigating the effects of two different diets on insulin sensitivity in young people with insulin resistance and/or pre-diabetes. BMC Public Health 2010;10:575 doi 10.1186/1471-2458-10-575
Public notes

Contacts
Principal investigator
Name 28840 0
A/Prof Sarah Garnett
Address 28840 0
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked bag 4001 Westmead NSW 2145
Country 28840 0
Australia
Phone 28840 0
+61 2 98453152
Fax 28840 0
Email 28840 0
[email protected]
Contact person for public queries
Name 11997 0
A/Prof Sarah Garnett
Address 11997 0
Division of Reseach
The Children's Hospital at Westmead
Locked Bag 4001
NSW 2145
Country 11997 0
Australia
Phone 11997 0
02 9845 3152
Fax 11997 0
02 9845 3170
Email 11997 0
[email protected]
Contact person for scientific queries
Name 2925 0
A/Prof Sarah Garnett
Address 2925 0
Division of Reseach
The Children's Hospital at Westmead
Locked Bag 4001
NSW 2145
Country 2925 0
Australia
Phone 2925 0
02 9845 3152
Fax 2925 0
02 9845 3170
Email 2925 0
[email protected]

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
EmbaseEffect of a prescriptive dietary intervention on psychological dimensions of eating behavior in obese adolescents.2013https://dx.doi.org/10.1186/1479-5868-10-119
EmbaseCan early weight loss, eating behaviors and socioeconomic factors predict successful weight loss at 12- and 24-months in adolescents with obesity and insulin resistance participating in a randomised controlled trial?.2016https://dx.doi.org/10.1186/s12966-016-0367-9
EmbaseImproved insulin sensitivity and body composition, irrespective of macronutrient intake, after a 12 month intervention in adolescents with pre-diabetes; RESIST a randomised control trial.2014https://dx.doi.org/10.1186/s12887-014-0289-0
N.B. These documents automatically identified may not have been verified by the study sponsor.