Trial reportDiabetes2011

Effects of metformin on body weight and body composition in obese insulin-resistant children: a randomized clinical trial.

Jack A Yanovski, Jonathan Krakoff, Christine G Salaita, Jennifer R McDuffie, Merel Kozlosky, Nancy G Sebring, James C Reynolds, Sheila M Brady, Karim A Calis

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, 2011. The graph read 3 numbers from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to trial NCT06611501 (Glycemic Regulation as Endometriosis Adjunct Treatment), which is not on this map. Cited by 82 papers, 9 of them syntheses that pooled it.

3numbers the graph read from it
1cell of the map it votes in
82citing papers in PubMed, 9 pooled it
10.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

← favours the treatmentfavours the comparator →
-5.200 · no effect
Body weight & compositionfavours the treatment · against placebo · obesity, t2dfeeds one cell of the map
Δ -0.07-0.12 to -0.01P = 0.02
Children prescribed metformin had significantly greater decreases in BMI (difference -1.09 kg/m(2), CI -1.87 to -0.31, P = 0.006), body weight (difference -3.38 kg, CI -5.2 to -1.57, P < 0.001), BMI Z score (difference between metformin and placebo groups -0.07, CI -0.12 to -0.01, P = 0.02), and fat mass (difference -1.40 kg, CI -2.74 to -0.06, P = 0.04).
Body weight & compositionfavours the treatment · against placebo · obesity, t2dfeeds one cell of the map
Δ -1.40-2.74 to -0.06P = 0.04
Children prescribed metformin had significantly greater decreases in BMI (difference -1.09 kg/m(2), CI -1.87 to -0.31, P = 0.006), body weight (difference -3.38 kg, CI -5.2 to -1.57, P < 0.001), BMI Z score (difference between metformin and placebo groups -0.07, CI -0.12 to -0.01, P = 0.02), and fat mass (difference -1.40 kg, CI -2.74 to -0.06, P = 0.04).
Body weight & compositionfavours the treatment · against placebo · obesity, t2dfeeds one cell of the map
Δ -3.38-5.20 to -1.57P < 0.001
Children prescribed metformin had significantly greater decreases in BMI (difference -1.09 kg/m(2), CI -1.87 to -0.31, P = 0.006), body weight (difference -3.38 kg, CI -5.2 to -1.57, P < 0.001), BMI Z score (difference between metformin and placebo groups -0.07, CI -0.12 to -0.01, P = 0.02), and fat mass (difference -1.40 kg, CI -2.74 to -0.06, P = 0.04).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Metformin×body weight & composition

SupportsOpen on the map →What to test next →

19 readable studies in this cell: 8 favour the treatment, 6 find no difference, 5 favour the comparator.

Belief with this paper
0.50contested · 8 families support, 4 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2011
Δ -0.07-0.12 to -0.01
NCT018093271,186 enrolled · 2013
Δ -0.90-1.60 to -0.20
NCT008598981,093 enrolled · 2009
Δ -1.37-2.03 to -0.71
NCT00643851994 enrolled · 2008
Δ -0.05-0.72 to 0.61
NCT02932475831 enrolled · 2017
Δ 0.04
NCT00676338820 enrolled · 2008
Δ -0.04-0.61 to 0.53
NCT02980276535 enrolled · 2017
Δ -0.70-1.30 to -0.20
Δ 17.05.00 to 29.0
increase 1.26-0.24 to 2.75
weight loss -16.2-60.2 to -4.40
4 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06611501 phase2active not recruitingnot on this mapstarted 2025, after this paper: background citation

Glycemic Regulation as Endometriosis Adjunct Treatment

TypeinterventionalSponsorBoston Children's HospitalRan2025 to 2027Enrolled14ConditionsPelvic Pain, EndometriosisArmsMetformin Hydrochloride, Placebo
5 · Its place in the literature

Who cites it

82 citing papers in PubMed, 9 syntheses or guidelines pooled it, 188 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline.The Journal of clinical endocrinology and metabolism · 2017 · on this map
    Guideline
  9. Drug interventions for the treatment of obesity in children and adolescents.The Cochrane database of systematic reviews · 2016
    Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Pressure To Be Thin and Insulin Sensitivity Among Adolescents.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2016
    Trial
  19. Trial
  20. Trial

22 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Jack A YanovskiUnit on Growth and Obesity, Program in Developmental Endocrinology and Genetics, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, Maryland, USA. jy15i@nih.gov
Jonathan Krakoff
Christine G Salaita
Jennifer R McDuffie
Merel Kozlosky
Nancy G Sebring
James C Reynolds
Sheila M Brady
Karim A Calis
National Institutes of Health Clinical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USNational Institute of Diabetes and Digestive and Kidney Diseases · US

Funding

Physiology, Psychology, and Genetics of ObesityZIAHD000641 · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · 2025 to 2025
$1.6M
Physiology, Psychology, and Genetics of ObesityZ01HD000641 · CHILD HEALTH AND HUMAN DEVELOPMENT · 1996 to 2005
Intramural NIH HHS Z01 HD000641
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

objectiveMetformin can decrease adiposity and ameliorate obesity-related comorbid conditions, including abnormalities in glucose homeostasis in adolescents, but there are few data evaluating the efficacy of metformin among younger children. Our objective was to determine whether metformin treatment causes weight loss and improves obesity-related comorbidities in obese children, who are insulin-resistant. RESEARCH DESIGN AND

methodsThis study was a randomized double-blind placebo-controlled trial consisting of 100 severely obese (mean BMI 34.6 ± 6.6 kg/m(2)) insulin-resistant children aged 6-12 years, randomized to 1,000 mg metformin (n = 53) or placebo (n = 47) twice daily for 6 months, followed by open-label metformin treatment for 6 months. All children and their parents participated in a monthly dietitian-administered weight-reduction program.

resultsEighty-five percent completed the 6-month randomized phase. Children prescribed metformin had significantly greater decreases in BMI (difference -1.09 kg/m(2), CI -1.87 to -0.31, P = 0.006), body weight (difference -3.38 kg, CI -5.2 to -1.57, P < 0.001), BMI Z score (difference between metformin and placebo groups -0.07, CI -0.12 to -0.01, P = 0.02), and fat mass (difference -1.40 kg, CI -2.74 to -0.06, P = 0.04). Fasting plasma glucose (P = 0.007) and homeostasis model assessment (HOMA) insulin resistance index (P = 0.006) also improved more in metformin-treated children than in placebo-treated children. Gastrointestinal symptoms were significantly more prevalent in metformin-treated children, which limited maximal tolerated dosage in 17%. During the 6-month open-label phase, children treated previously with placebo decreased their BMI Z score; those treated continuously with metformin did not significantly change BMI Z score further.

conclusionsMetformin had modest but favorable effects on body weight, body composition, and glucose homeostasis in obese insulin-resistant children participating in a low-intensity weight-reduction program.

Indexed as

Body CompositionBody WeightChildDouble-Blind MethodFemaleHumansHypoglycemic AgentsInsulin ResistanceMaleMetforminObesityTreatment OutcomeHypoglycemic AgentsMetformin

Identifiers

PMID21228310
PMCPMC3028347
OpenAlexW2110798021

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.