Trial	Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a		Endpoints quoted in publication(s)b	Time of measurement
Atabek 2008	N/T		Primary outcome measures: ‐	6 months
			Secondary outcome measures : ‐
			Other outcome measures: % change in BMI, DBP, SBP, pulse rate, lipids, triglycerides, serum insulin, serum glucose, HOMA, HDL, BMI z score, LDL, total cholesterol, weight change, adverse events
Berkowitz 2003	Source:NCT00212173 (added 13 September 2005) Primary outcome measure(s): BMI, weight	No trial results posted. No link to Berkowitz 2003 publication but links to 2 additional publications. A second protocol for an adolescent lifestyle intervention also included	Primary outcome measure: % change in BMI	3, 6, 9, 12 months
	Secondary outcome measure(s): BP, lipids, glucose, insulin		Secondary outcome measures: BP, pulse, hunger
	Other outcome measure(s): ‐		Other outcome measures: lipids, triglycerides, serum insulin, serum glucose, HOMA, HDL, BMI z score, LDL, total cholesterol, weight change, waist circumference, adverse events
Berkowitz 2006	Source:NCT00261911 Primary outcome measure(s): absolute change in BMI from baseline to endpoint (12 months)	No trial results posted, publications specified	Primary outcome measures: absolute change from baseline in BMI	0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months
	Secondary outcome measure(s): % change from baseline in BMI, proportions of participants achieving ≥ 5% and ≥ 10% BMI and bodyweight reduction, absolute and % change from baseline in waist circumference, body composition (DEXA), lipid and glycaemic variables (all: 12 months)		Secondary outcome measures: % change in BMI, proportion of participants achieving reductions in BMI of ≥ 5% or ≥ 10%, absolute and % changes in bodyweight and lipid and glycaemic variables, absolute change in waist circumference
	Other outcome measure(s): ‐		Other outcome measures: DBP, SBP, pulse rate, QTc interval, maturation (Tanner staging), adverse events
Chanoine 2005	N/T		Primary outcome measures: change in BMI from baseline to trial end (or trial exit)	‐0.5, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12 months
			Secondary outcome measures: change in bodyweight, levels of total, HDL and LDL cholesterol, LDL‐to‐HDL cholesterol ratio, triglyceride levels, SBP and DBP, waist and hip circumference, glucose and insulin responses to an oral glucose challenge, and changes in body composition
			Other outcome measures: beta carotene, vitamin A, 25‐hydroxyvitamin D, vitamin E, Tanner staging, adverse events
Clarson 2009	N/T		Primary outcome measures: change in BMI and modification of metabolic risk factors, including insulin resistance, plasma lipids and adipocytokines, assessment of metformin on the attainment of a target metabolic profile	6 months
			Secondary outcome measures: ‐
			Other outcome measures: BMI z score, BP, adverse events, waist circumference
Franco 2014	N/T		Primary outcome measures: ‐	On average every 40 days for 13 months
			Secondary outcome measures: ‐
			Other outcome measures: % of participants loosing 10% of their initial weight, weight, BMI, SBP, DBP, cholesterol, LDL, HDL, triglycerides, leptin, CRP, transaminases, blood glucose, insulin, adverse events, waist circumference
Freemark 2001	N/T		Primary outcome measures: ‐	6 months
			Secondary outcome measures: ‐
			Other outcome measures: BMI SDS, insulin, glucose tolerance, leptin, serum lipids, HbA1c, IGF‐1, lactate, cholesterol, LDL, HDL, LDL/HDL, triglycerides, adverse events, ALT, AST
Garcia‐Morales 2006	N/T		Primary outcome measures: baseline versus endpoint absolute values for bodyweight, BMI, and % of the initial BMI (%BMI)	‐15, 30, 60, 90, 120, 150, 180 days
			Secondary outcome measures: waist circumference and % of the initial waist circumference (%waist)
			Other outcome measures: health‐related quality of life, white blood cells, monocytes, eosinophils, glucose, uric acid, creatinine, albumin, chloride, total cholesterol, LDL, AST, alkaline phosphatase, SBP, DBP, heart rate, ST segment, adverse events
Godoy‐Matos 2005	N/T		Primary outcome measures: change in weight and BMI	‐4, 4, 8, 12, 16, 20, 24 weeks
			Secondary outcome measures: change in waist, hip, and waist‐to‐hip ratio
			Other outcome measures: SBP, DBP, heart rate, glucose, total cholesterol, triglycerides, HDL, LDL, VLDL, insulin, total cholesterol/HDL cholesterol, left atrium diameter, left ventricular mass, adverse events, satiety score
Kendall 2013	Source:ISRCTN19517475 Primary outcome measure: reduction in BMI SDS	Prior to 16 December 2008: 80 participants aged 9 to 18 years As of 16 December 2008: pubertal and postpubertal children: fasting insulin > 26 mIU/L prepubertal children: fasting insulin > 15 mIU/L 120‐minute insulin > 89 mIU/L or impaired glucose tolerance (OGTT 2‐hour plasma glucose value ≥ 7.8 to < 11.1 (± impaired fasting glucose ≥ 6.1 to < 7), or both	Primary outcome measure: reduction of BMI SDS	3, 6 months
	Secondary outcome measures: Added 16 December 2008: fasting and 2‐hour insulin and glucose levels on OGTT, measures of insulin resistance, fasting lipids, CRP, adiponectin, leptin, resistin, BP		Secondary outcome measures: BMI and waist‐to‐hip ratio, fasting and postprandial insulin and glucose levels, metabolic risk factors, adipokines
	Other outcome measure(s): ‐		Other outcome measures: weight, height, SBP, DBP, cholesterol, HDL, LDL, triglycerides, bilirubin, CRP, lactate, resistin, adverse events
Maahs 2006	N/T		Primary outcome measures: change in BMI from baseline to 6 months	1, 2, 3, 4, 5, 6 months
			Secondary outcome measures: changes in weight, lean body mass, results of blood chemistry studies
			Other outcome measures: health‐related quality of life, all‐cause mortality, vitamin A, vitamin D, vitamin E, adverse events
Mauras 2012	Source:NCT00139477 Primary outcome measures: change from baseline in hsCRP at 6 months, change from baseline in fibrinogen at 6 months, change from baseline in IL‐6 at 6 months, change from baseline in PAI‐1 at 6 months	Trial results posted, publications specified	Primary outcome measures: hsCRP and fibrinogen concentrations at 6 months	3, 6 months
	Secondary outcome measure(s): ‐		Secondary outcome measures: ‐
	Other outcome measure(s): ‐		Other outcome measures: weight, BMI percentile, systolic BP, diastolic BP, IL‐6, PAI‐1, adiponectin, IGF‐1, insulin, total cholesterol, LDL‐cholesterol, HDL‐cholesterol, triglycerides, free fatty acids, glucose tolerance, resting energy expenditure rates, adverse events, waist circumference
NCT00001723	Source:NCT00001723 Primary outcome measure: change in BMI SDS (time frame: baseline to 6 months)	Trial results posted, linked to pilot trial but no link to publication	No publication available	6 months
	Secondary outcome measures: change in bodyweight (time frame: baseline to 6 months), weight, change in BMI (time frame: baseline to 6 months), change in body fat (time frame: baseline to 6 months), body fat distribution measures obtained DEXA, effect of race on change in weight (time frame: baseline to 6 months), difference in change of weight according to race (non‐Hispanic white versus non‐Hispanic black)
	Other outcome measure(s): ‐
Ozkan 2004	N/T		Primary outcome measures: ‐	1 to 15 months
			Secondary outcome measures: ‐
			Other outcome measures: weight change, % weight change, BMI, adverse events
Prado 2012	N/T		Primary outcome measures: weight	1, 2, 3, 4, 5, 6 months
			Secondary outcome measures: ‐
			Other outcome measures: BMI, motivational survey results, glycaemia, afterload glucose, HDL, adverse events, waist circumference
Rezvanian 2010	N/T		Primary outcome measures: ‐	12, 24 weeks
			Secondary outcome measures: ‐
			Other outcome measures: BMI, BMI SDS, waist circumference, waist‐to‐height ratio, adverse events
Srinivasan 2006	Source:ISRCTN43267711 Primary outcome measures: ‐	No results posted or links to publication Retrospectively registered	Primary outcome measures: ‐	6, 12 months
	Secondary outcome measures: ‐		Secondary outcome measures: ‐
	Other outcome measures: ‐		Other outcome measures: BMI, waist circumference z score, fasting insulin, fasting glucose, glucose effectiveness, acute insulin response, disposition index, glucose disposal, acanthosis nigricans neck score, Tanner staging, weight loss, weight z score, BMI z score, adverse events
Van Mil 2007	N/T		Primary outcome measure: change in BMI between the 2 periods (12 weeks' randomised treatment period and 12 weeks' follow‐up)	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 weeks
			Secondary outcome measures: ‐
			Other outcome measures: height, weight, sleeping metabolic rate, basal metabolic rate, total energy expenditure, physical activity level, basal metabolic rate adjusted, total energy expenditure residuals, adverse events
Wiegand 2010	Found in the references of included trials section: EudraCT Nr. 2004‐003816‐47 (but currently not available at EU CTR. We contacted EMA and received the following answer "Note that this trial is not in the public domain due to missing information from Ethics Committee therefore we recommend you to contact the National Competent Authority concerned by this application."; in the dissertation by Hübel it is specified "Vor Beginn der Studie wurde die Zustimmung der jeweils zuständigen Ethikkommissionen eingeholt (Charité Berlin, Deutschland; St. Gallen, Schweiz)" ‐ "before start of the study approval of the appropriate ethics committees was obtained (Charité Berlin, Germany; St. Gallen, Switzerland))		Primary outcome measures: HOMA‐IR	‐6, 3, 6 months
			Secondary outcome measures: anthropometric measurements (BMI and waist‐to‐hip ratio), cardiovascular risk parameters (SBP and DBP), lipid profile (total, LDL, HDL cholesterol and triglycerides), and other metabolic parameters (glucose tolerance and fasting insulin)
			Other outcome measures: adverse events
Wilson 2010	Source:NCT00209482 and NCT00120146 Primary outcome measures: NCT00209482: mean change from baseline in individual BMIs between the 2 groups (compared at 2 time points: at week 52 and week 100) NCT00120146: change in BMI, BMI	No trial results posted, publications specified	Primary outcome measures: BMI change, BMI z score	‐4, 12, 24, 36, 48, 60, 72, 84, 96 weeks
	Secondary outcome measures: NCT00209482: ‐ NCT00120146: change in insulin sensitivity; fasting insulin concentrations; characterisation of insulin dynamics and insulin sensitivity; characterisation of fat distribution and fatty infiltration of the liver; use of CT to characterise abdominal fat distribution; use of CT and ALT levels to assess fatty infiltration of the liver; characterisation of body composition; characterisation of dietary amino acids; characterisation of the insulin‐to‐glucagon ratio; characterisation of the impact of sex on response to metformin XR; characterisation of the impact of race/ethnicity on response to metformin XR; characterisation of health‐related quality of life		Secondary outcome measures: fat mass, lean mass, fat area, HOMA‐IR, area under insulin curve, area under glucose curve, corrected insulin release at glucose peak, LDL cholesterol, HDL cholesterol, triglycerides, triglyceride‐to‐HDL cholesterol ratio, adverse events
	Other outcome measures: NCT00209482: ‐ NCT00120146: ‐		Other outcome measures: waist circumference
Yanovski 2011	Source:NCT00005669 Primary outcome measures: changes in bodyweight as determined by BMI SDS (6 months)	Trial results posted, publications specified	Primary outcome measures: change in BMI SD score (BMI z score), as determined at the end of the 6‐month randomised treatment phase	1, 2, 3, 4, 5, 6 months
	Secondary outcome measures: change in bodyweight as determined by BMI (6 months), change in bodyweight (6 months), change in body fat by DEXA (6 months), change in body fat by Bod Pod (6 months)		Secondary outcome measures: changes in BMI, bodyweight and fat mass at the conclusion of the randomised phase
	Other outcome measures: ‐		Other outcome measures: changes in skinfold thickness, body circumferences, visceral adipose tissue, insulin resistance and laboratory components of the metabolic syndrome ‐ SBP, DBP, serum insulin, plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, LDL‐to‐HDL cholesterol ratio, triglycerides, ALT, AST, hsCRP, vitamin B12, adverse events
‐ denotes not reported. aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturer's websites, trial registers). bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents or multiple reports of a primary trial). ALT: alanine transaminase; AST: aspartate transaminase; BMI: body mass index; BMI SDS: body mass index standardised deviation score; BP: blood pressure; CDC: Centers for Disease Control and Prevention; CRP: C‐reactive protein; CT: computed tomography; DBP: diastolic blood pressure; DEXA: dual‐energy X‐ray absorptiometry; EMA: European Medicines Agency; EU CTR: European Clinical Trials Register; FDA: Food and Drug Administration (US); HbA1c: glycosylated haemoglobin A1c; HDL: high‐density lipoprotein; HOMA(‐IR): homeostasis model assessment (insulin resistance); hsCRP: high sensitivity C‐reactive protein; IGF‐1: insulin‐like growth factor 1; IL‐6: interleukin‐6; LDL: low‐density lipoprotein; N/T: no trial document available; OGTT: oral glucose tolerance test; PAI‐1: plasminogen activator inhibitor‐1; QTc: heart‐rate corrected QT interval; SBP: systolic blood pressure; VLDL: very low density lipoprotein; XR: extended release.