Evidence map›Metformin × body weight & composition›PMID 36746160›Full record

Trial reportThe lancet. Diabetes & endocrinology2023

Outcomes in children of women with type 2 diabetes exposed to metformin versus placebo during pregnancy (MiTy Kids): a 24-month follow-up of the MiTy randomised controlled trial.

Denice S Feig, J Johanna Sanchez, Kellie E Murphy, Elizabeth Asztalos, Bernard Zinman, David Simmons, Andrea M Haqq, I George Fantus, Lorraine Lipscombe, Anthony Armson and 10 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2023. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. It is linked to trial NCT01832181 (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial), which is not on this map. Cited by 25 papers, 5 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
25citing papers in PubMed, 5 pooled it
16.2field-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 →
-0.310.450 · no effect
Body weight & compositionno clear difference · against placebo · t2d, gdmfeeds one cell of the map
Δ 0.07-0.31 to 0.45p=0.72
At 24 months, there was no difference between groups in mean BMI Z score (0.84 [SD 1.52] with metformin vs 0.91 [1.38] with placebo; mean difference 0.07 [95% CI -0.31 to 0.45], p=0.72) or mean sum of skinfolds (23.0 mm [5.2] vs 23.8 mm [5.4]; mean difference 0.8 mm [-0.7 to 2.3], p=0.31).
FeedsMetformin×body weight & composition

Read, but not usablea number the graph found but could not read as for or against

Body weight & compositionan association or prognostic statement, not a treatment comparison · against placebo · t2d, gdmfeeds one cell of the map
Δ -0.01-0.42 to 0.37p=0.92
Metformin was not a predictor of BMI Z score at 24 months of age (mean difference -0.01 [95% CI -0.42 to 0.37], p=0.92).
FeedsMetformin×body weight & composition

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

InconclusiveOpen on the map →What to test next →

19 readable studies in this cell: 7 favour the treatment, 6 find no difference, 6 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 comparatorfavours the treatment →
0 · no effect
This paper · 2023
Δ 0.07-0.31 to 0.45
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
Effect of Metformin Added to Insulin on Glycemic Control Among Overwei…PMID 26624824 · 164 enrolled · 2013
Δ 17.05.00 to 29.0
Weight and Glucose Reduction Observed with a Combination of Nutritiona…PMID 27093610 · 53 enrolled · 2013
increase 1.26-0.24 to 2.75
A randomized, 48-week, placebo-controlled trial of intensive lifestyle…PMID 15302293 · 2004
weight loss -16.2-60.2 to -4.40
Efficacy and safety of ipragliflozin as an add-on therapy to sitaglipt…PMID 29862619 · 2018
Δ -1.72
Effects of metformin on the body composition in subjects with risk fac…PMID 15715892 · 2005
increase 16.5
Metformin for the prevention of diabetes among people with HIV and eit…PMID 37460828 · 2023
Δ -1.47-2.58 to -0.35
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.

NCT01832181 completednot on this map

Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)

TypeobservationalSponsorMount Sinai Hospital, CanadaRan2013 to 2021Enrolled287ConditionsType 2 Diabetes
5 · Its place in the literature

Who cites it

25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Metformin + Insulin vs. Insulin for GDM and T2DM during pregnancy: systematic review and meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2026 · on this map
    Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Drug Therapies for Diabetes.International journal of molecular sciences · 2023
    Review
  18. Antidiabetic Therapy during Pregnancy: The Prescription Pattern in Italy.International journal of environmental research and public health · 2023
    Article
  19. Article
  20. Review
6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

20 authors at 6 institutions in 2 countries.

Denice S FeigDepartment of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada. Electronic address: d.feig@utoronto.ca.
J Johanna SanchezSunnybrook Research Institute, Toronto, ON, Canada.
Kellie E MurphyDepartment of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.
Elizabeth AsztalosSunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Bernard ZinmanDepartment of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.
David SimmonsDepartment of Medicine, Western Sydney University, Sydney, NSW, Australia.
Andrea M HaqqDepartment of Pediatrics, University of Alberta, Edmonton, AB, Canada.
I George FantusDepartment of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada; Department of Medicine and Research Institute, McGill University Health Center, McGill University, Montreal, QC, Canada.
Lorraine LipscombeDepartment of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, Women's College Hospital, Toronto, ON, Canada.
Anthony ArmsonDepartment of Obstetrics and Gynecology, Dalhousie University, Halifax, NS, Canada.
Jon BarrettSunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Lois DonovanDepartment of Medicine and Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Alberta Children's Hospital Research Institute, Calgary, AB, Canada.
Paul KaranicolasSunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Siobhan TobinSunnybrook Research Institute, Toronto, ON, Canada.
Kathryn MangoffSunnybrook Research Institute, Toronto, ON, Canada.
Gail KleinSunnybrook Research Institute, Toronto, ON, Canada.
Yidi JiangSunnybrook Research Institute, Toronto, ON, Canada.
George TomlinsonDepartment of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, University Health Network, Toronto, ON, Canada.
Jill HamiltonDepartment of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
MiTy Kids Collaborative Group
Sunnybrook Hospital · CASunnybrook Research InstituteUniversity of Alberta · CAWestern Sydney University · AUDalhousie University · CAUniversity of Toronto · CA

Funding

CIHR
8 · The paper itself

Abstract

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

backgroundMetformin is increasingly being used during pregnancy, with potentially adverse long-term effects on children. We aimed to examine adiposity in children of women with type 2 diabetes from the Metformin in Women with Type 2 Diabetes in Pregnancy (MiTy) trial, with and without in-utero exposure to metformin, up to 24 months of age.

methodsMiTy Kids is a follow-up study that included infants of women who participated in the MiTy randomised controlled trial, receiving either oral 1000 mg metformin twice daily or placebo. Caregivers and researchers remained masked to the type of medication (metformin or placebo) mothers received during their pregnancy. Anthropometric measurements, including weight, height, and skinfold thicknesses, were taken at 3, 6, 12, 18, and 24 months. At 24 months, linear regression was used to compare the BMI Z score and sum of skinfolds in the metformin versus placebo groups, adjusted for confounders. Fractional polynomials were used to assess growth trajectories. This study is registered with ClinicalTrials.gov, NCT01832181.

findingsOf the 465 eligible children, 283 (61%) were included from 19 centres in Canada and Australia. At 24 months, there was no difference between groups in mean BMI Z score (0·84 [SD 1·52] with metformin vs 0·91 [1·38] with placebo; mean difference 0·07 [95% CI -0·31 to 0·45], p=0·72) or mean sum of skinfolds (23·0 mm [5·2] vs 23·8 mm [5·4]; mean difference 0·8 mm [-0·7 to 2·3], p=0·31). Metformin was not a predictor of BMI Z score at 24 months of age (mean difference -0·01 [95% CI -0·42 to 0·37], p=0·92). There was no overall difference in BMI trajectory but, in males, trajectories were significantly different by treatment (p=0·048); BMI in the metformin group was higher between 6 and 24 months. Children of women with type 2 diabetes were approximately 1 SD heavier than the WHO reference population.

interpretationAnthropometrics were similar in children exposed and those not exposed to metformin in utero; hence, overall, data are reassuring with regard to the use of metformin during pregnancy in women with type 2 diabetes and the long-term health of their children.

fundingCanadian Institute for Health Research.

Indexed as

Diabetes Mellitus, Type 2MetforminCanadaChildFemaleFollow-Up StudiesHumansHypoglycemic AgentsInfantPregnancyHypoglycemic AgentsMetformin

Identifiers

PMID36746160
OpenAlexW4319067708

What Socratic holds

Texttitle and abstract
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.