Trial | Intervention(s) and comparator(s) | Duration of intervention (duration of follow‐up) | Description of participants | Trial period (year to year) | Country | Setting | Ethnic groups (%) | Duration of obesity (mean years (SD)) |
Atabek 2008 | I: metformin + diet and physical activity advice | 6 months (6 months) | Obese adolescents with hyperinsulinaemia | ‐ | Turkey | Hospital in/outpatient clinic/other based in University School of Medicine | ‐ | ‐ |
C: placebo + diet and physical activity advice | ||||||||
Berkowitz 2003 | I: behavioural programme + sibutramine | 6 months (6 months) | Obese adolescent boys and postmenarchal girls | March 1999 to August 2002 | USA | University of Pennsylvania School of Medicine | White 49, black 49, other 2 | ‐ |
C: behavioural programme + placebo | White 62, black 33, other 5 | |||||||
Berkowitz 2006 | I: behavioural therapy programme + sibutramine | 12 months (12 months) | Obese adolescents | July 2000 to February 2002 | USA | 33 weight loss clinics and outpatient clinic based in a University School of Medicine | White 56, African‐American 22, Hispanic or Mexican American 16, other 6 | ‐ |
C: behavioural therapy programme + placebo | White 59, African‐American 19, Hispanic or Mexican‐American 14, other 9 | |||||||
Chanoine 2005 | I: orlistat + diet + exercise + behavioural therapy | 54 weeks (54 weeks) | Obese adolescents | August 2000 to October 2002 | USA and Canada | 32 clinical centres | White 75, black 19, other 6 | ‐ |
C: placebo + diet + exercise + behavioural therapy | White 78, black 14, other 8 | |||||||
Clarson 2009 | I: metformin + lifestyle intervention | 6 months (6 months) | Obese adolescents with insulin resistance | Enrolled 2005 to 2007 | Canada | Participants assessed in community clinic and there were monthly visits to clinic during intervention. Intervention carried out in community ‐ at adolescent's home ‐ unclear where group sessions took place | ‐ | ‐ |
C: lifestyle intervention only | ||||||||
Franco 2014 | I: sibutramine + dietary guidance | 6 months (6 months) | Obese adolescents | ‐ | Brazil | Paediatric endocrinology outpatient clinic in childhood obesity group of the Instituto da Crianca do Hospital das Clinicas de Faculdade de Medicina de Universidade de Sao Paulo | ‐ | ‐ |
C: placebo + dietary guidance | ||||||||
Freemark 2001 | I: metformin | 6 months (6 months) | Obese adolescents with fasting hyperinsulinaemia and a family history of type 2 diabetes | ‐ | USA | Inpatient and outpatient clinic of a university | White 64, black 36 | ‐ |
C: placebo | White 47, black 53 | |||||||
Garcia‐Morales 2006 | I: sibutramine + diet + exercise | 6 months (6 months) | Obese Mexican adolescents | August 2001 to August 2003 | Mexico | Outpatients attending the endocrinology department of the Federico Gomez Children's Hospital of Mexico | ‐ | ‐ |
C: placebo + diet + exercise | ||||||||
Godoy‐Matos 2005 | I: sibutramine + hypocaloric diet + exercise | 7 months (7 months) | Obese adolescents | January 2002 to April 2003 | Brazil | Regular clinical setting | ‐ | ‐ |
C: placebo + hypocaloric diet + exercise | ||||||||
Kendall 2013 | I: metformin + healthy lifestyle advice | 6 months (6 months) | Obese children and adolescents with hyperinsulinaemia or impaired fasting glucose or impaired glucose tolerance (or both) | ‐ | UK | UK paediatric endocrine centres | White 80, Asian 19, Afro‐Caribbean 11 | ‐ |
C: placebo + healthy lifestyle advice | White 72, Asian 26, Afro‐Caribbean 1 | |||||||
Maahs 2006 | I: orlistat + diet and exercise therapy | 26 weeks (26 weeks) | Obese adolescents | December 2002 to September 2003 | USA | General clinical research centre at University of New Mexico Hospital | Hispanic 60 | ‐ |
C: placebo + diet and exercise therapy | Hispanic 65 | |||||||
Mauras 2012 | I: metformin + diet/exercise intervention | 6 months (6 months) | Obese children with normal glucose tolerance but elevated hsCRP or fibrinogen concentrations (or both) | ‐ | USA | ‐ | White 51, African‐American 37, other 11 | Uncomplicated (exogenous) obesity for < 5 years |
C: diet/exercise intervention | White 39, African‐American 42, other 19 | |||||||
NCT00001723 | I: orlistat + behavioural weight loss programme | 6 months (6 months) | Obese children and adolescents with obesity‐related diseases | RCT began in 1999 and ended in 2008 | USA | National Institutes of Health Clinical Center | Non‐Hispanic black 63, non‐Hispanic white 37 |
‐ |
C: placebo + behavioural weight loss programme | Non‐Hispanic black 60, non‐Hispanic whites 40 |
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Ozkan 2004 | I: conventional treatment + orlistat | Intervention group was followed for 5 to 15 months (mean duration of treatment 11.7, SD 3.7 months) | Adolescents with severe exogenous obesity | ‐ | Turkey | Outpatient clinic | ‐ | ‐ |
C: conventional treatment | Control group was followed for 6 to 17 months (mean 10.2, SD 3.7 months) | |||||||
Prado 2012 | I: metformin + nutritional guide and exercise programme | 3 months (6 months) | Obese female adolescents at risk of developing type 2 diabetes | June 2009 to July 2010 | Chile | Conducted at Center of Adolescent Health Serjoven | ‐ | ‐ |
C: placebo + nutritional guide and exercise programme | ||||||||
Rezvanian 2010 | I1: metformin + healthy eating and physical activity advice | 12 weeks (24 weeks) | Obese children and adolescents | ‐ | Iran | Pediatric Obesity and Metabolic Syndrome Research Clinic of the Pediatric Preventive Cardiology Department, Isfahan Cardiovascular Research Center | ‐ | ‐ |
I2: fluoxetine + healthy eating and physical activity advice | ||||||||
I3: metformin and fluoxetine + healthy eating and physical activity advice | ||||||||
C: placebo + healthy eating and physical activity advice | ||||||||
Srinivasan 2006 | I: metformin first then placebo + standardised information on healthy eating and exercise | 6 months (12 months) | Obese children and adolescents (aged 9 to 18) with suspected insulin resistance | ‐ | Australia | Outpatient clinic of a tertiary paediatric hospital (university teaching hospital) | 64% were from ethnic backgrounds with high prevalence of insulin resistance and the metabolic syndrome (e.g. Indian subcontinent, Pacific Islands), 25% were from a northern European background, and 11% were from a mixed background | ‐ |
C: placebo first then metformin + standardised information on healthy eating and exercise | ||||||||
Van Mil 2007 | I: sibutramine + energy‐restricted diet and exercise plan | 12 weeks (24 weeks) | Obese adolescents | ‐ | The Netherlands | Outpatient clinic | ‐ | ‐ |
C: placebo + energy‐restricted diet and exercise plan | ||||||||
Wiegand 2010 | I: metformin + multiprofessional lifestyle intervention | 6 months (6 months) | Obese insulin‐resistant adolescents | May 2006 to December 2006 | Germany and Switzerland | Paediatric obesity centre | White 87, other 13 | ‐ |
C: placebo + multiprofessional lifestyle intervention | White 92, other 9 | |||||||
Wilson 2010 | I: metformin + lifestyle intervention programme | 52 weeks (100 weeks) | Obese adolescents | October 2003 to August 2007 | USA | 6 Glaser paediatric research centres | White 56, African‐American 21, Asian 8, other 15, Hispanic ethnicity 18 | ‐ |
C: placebo + lifestyle intervention programme | White 71, African‐American 16, Asian 0, other 13, Hispanic ethnicity 29 | |||||||
Yanovski 2011 | I: metformin + dietitian‐administered weight‐reduction programme | 6 months (12 months) | Obese insulin‐resistant children | September 2000 to August 2008 | USA | Trial took place at the NIH clinical research centre | Non‐Hispanic white 42, Non‐Hispanic black 42, Hispanic white 11, other 5 | ‐ ‐ |
C: placebo + dietitian‐administered weight‐reduction programme | Non‐Hispanic white 49, Non‐Hispanic black 38, Hispanic white 11, other 2 | |||||||
"‐" denotes not reported. C: comparator; hsCRP: high sensitivity C‐reactive protein; I: intervention; RCT: randomised controlled trial; SD: standard deviation. |