ANZCTR - Registration

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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]

TGA 2008/520

Universal Trial Number (UTN)

Trial acronym

RESIST

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Clinical insulin resistance

Pre-diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

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]

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]

Baseline, 3 months, 6 months, 12 months

Secondary outcome [1]

Insulin sensitivity index (OGTT) and adiposity will be measured by dual energy x-ray absorptiometry and anthropometry

Timepoint [1]

24 months

Secondary outcome [2]

Adiposity. Adiposity will be measured by dual energy x-ray absorptiometry and anthropometry

Timepoint [2]

Baseline, 3 months, 6 months, 12 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?

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]

Charities/Societies/Foundations

Name [1]

BUPA Foundation

Address [1]

50 Bridge Street
Sydney NSW 2000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Diabetes Australia Research Trust

Address [2]

Diabetes Australia
GPO BOX 3156
CANBERRA ACT 2601
Level 2, 103-105 Northbourne Ave
TURNER ACT 2612

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

The Heart Foundation

Address [3]

Level 3, 80 William Street NSW 2011

Country [3]

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]

Individual

Name [1]

Chris Cowell

Address [1]

Division of Research
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2001

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Louise Baur

Address [1]

Clinical School
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Manny Noakes

Address [2]

Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041
Adelaide SA 5000

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Helen Woodhead

Address [3]

Department of Paediatrics
Campbelltown Hospital
Terry Road
Campbelltown NSW 2560

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Kate Steinbeck

Address [4]

Metabolism and Obesity Services
Royal Prince Alfred Hospital
Camperdown NSW

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Alexandra Hospital for Children

Ethics committee address [1]

Locked Bag 4001
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/06/2008

Ethics approval number [1]

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

A/Prof Sarah Garnett

Address

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked bag 4001 Westmead NSW 2145

Country

Australia

Phone

+61 2 98453152

Fax

sarah.garnett@health.nsw.gov.au

Contact person for public queries

Name

Sarah Garnett

Address

Division of Reseach
The Children's Hospital at Westmead
Locked Bag 4001
NSW 2145

Country

Australia

Phone

02 9845 3152

Fax

02 9845 3170

sarah.garnett@health.nsw.gov.au

Contact person for scientific queries

Name

Sarah Garnett

Address

Division of Reseach
The Children's Hospital at Westmead
Locked Bag 4001
NSW 2145

Country

Australia

Phone

02 9845 3152

Fax

02 9845 3170

sarah.garnett@health.nsw.gov.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

Source	Title	Year of Publication	DOI
Embase	Effect of a prescriptive dietary intervention on psychological dimensions of eating behavior in obese adolescents.	2013	https://dx.doi.org/10.1186/1479-5868-10-119
Embase	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.	2014	https://dx.doi.org/10.1186/s12887-014-0289-0
Embase	Can 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?.	2016	https://dx.doi.org/10.1186/s12966-016-0367-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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