Metformin extended release treatment of adolescent obesity

A 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up

Darrell M. Wilson, Stephanie H. Abrams, Tandy Aye, Phillip D.K. Lee, Carine Lenders, Robert H. Lustig, Stavroula V. Osganian, Henry A. Feldman, Patricia Fechner, Thomas Robinson, Bruce Buckingham, Trudy Esrey, Keniki McNeil, Beatrice Sorensen, Kirsten Wilson, Jeanne Davis, William Klish, Stephanie Abrams, Pam Holt, Cynthia Edwards & 28 others Linda Howard, Stephen Gitelman, Marcia Wertz, Jessica Breland, Tania Lihatsh, Anna Haddal, Pinchas Cohen, Sally Shupien, Janet Mooney, Elena Khanukhova, Helene Cohen, George Taylor, Christopher Duggan, Sam Nurko, Carol Sweeney, Katie Zhang, Maggie McCarthy, Michael Wake, Rajna Filip-Dhima, Charles Prober, Karen Urbanek, Alisa Kim, Anita Kelley, Christine Crabtree, Dennis Styne, Michael Gottschalk, Daniel Hale, Heidi Krause-Steinrauf

Research output: Contribution to journalArticle

84 Citations (Scopus)

Abstract

Background: Metformin has been proffered as a therapy for adolescent obesity, although long-term controlled studies have not been reported. Objective: To test the hypothesis that 48 weeks of daily metformin hydrochloride extended release (XR) therapy will reduce body mass index (BMI) in obese adolescents, as compared with placebo. Design: Multicenter, randomized, double-blind, placebocontrolled clinical trial. Setting: The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007. Participants: Obese (BMI≥95th percentile) adolescents (aged 13-18 years) were randomly assigned to the intervention (n=39) or placebo groups. Intervention: Following a 1-month run-in period, subjects following a lifestyle intervention program were randomized 1:1 to 48 weeks' treatment with metformin hydrochloride XR, 2000mgonce daily, or an identical placebo. Subjects were monitored for an additional 48 weeks. Main Outcome Measure: Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo. Results: After 48 weeks, mean (SE) adjusted BMI increased 0.2 (0.5) in the placebo group and decreased 0.9 (0.5) in the metformin XR group (P=.03). This difference persisted for 12 to 24 weeks after cessation of treatment. No significant effects of metformin on body composition, abdominal fat, or insulin indices were observed. Conclusion: Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program. Trial Registration: clinicaltrials.gov Identifiers: NCT00209482 and NCT00120146.

Original languageEnglish (US)
Pages (from-to)116-123
Number of pages8
JournalArchives of Pediatrics and Adolescent Medicine
Volume164
Issue number2
DOIs
StatePublished - Feb 1 2010

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Pediatric Obesity
Metformin
Placebos
Body Mass Index
Therapeutics
Life Style
Abdominal Fat
Withholding Treatment
Body Composition
Outcome Assessment (Health Care)
Clinical Trials
Insulin
Pediatrics
Research

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

Wilson, Darrell M. ; Abrams, Stephanie H. ; Aye, Tandy ; Lee, Phillip D.K. ; Lenders, Carine ; Lustig, Robert H. ; Osganian, Stavroula V. ; Feldman, Henry A. ; Fechner, Patricia ; Robinson, Thomas ; Buckingham, Bruce ; Esrey, Trudy ; McNeil, Keniki ; Sorensen, Beatrice ; Wilson, Kirsten ; Davis, Jeanne ; Klish, William ; Abrams, Stephanie ; Holt, Pam ; Edwards, Cynthia ; Howard, Linda ; Gitelman, Stephen ; Wertz, Marcia ; Breland, Jessica ; Lihatsh, Tania ; Haddal, Anna ; Cohen, Pinchas ; Shupien, Sally ; Mooney, Janet ; Khanukhova, Elena ; Cohen, Helene ; Taylor, George ; Duggan, Christopher ; Nurko, Sam ; Sweeney, Carol ; Zhang, Katie ; McCarthy, Maggie ; Wake, Michael ; Filip-Dhima, Rajna ; Prober, Charles ; Urbanek, Karen ; Kim, Alisa ; Kelley, Anita ; Crabtree, Christine ; Styne, Dennis ; Gottschalk, Michael ; Hale, Daniel ; Krause-Steinrauf, Heidi. / Metformin extended release treatment of adolescent obesity : A 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up. In: Archives of Pediatrics and Adolescent Medicine. 2010 ; Vol. 164, No. 2. pp. 116-123.
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abstract = "Background: Metformin has been proffered as a therapy for adolescent obesity, although long-term controlled studies have not been reported. Objective: To test the hypothesis that 48 weeks of daily metformin hydrochloride extended release (XR) therapy will reduce body mass index (BMI) in obese adolescents, as compared with placebo. Design: Multicenter, randomized, double-blind, placebocontrolled clinical trial. Setting: The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007. Participants: Obese (BMI≥95th percentile) adolescents (aged 13-18 years) were randomly assigned to the intervention (n=39) or placebo groups. Intervention: Following a 1-month run-in period, subjects following a lifestyle intervention program were randomized 1:1 to 48 weeks' treatment with metformin hydrochloride XR, 2000mgonce daily, or an identical placebo. Subjects were monitored for an additional 48 weeks. Main Outcome Measure: Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo. Results: After 48 weeks, mean (SE) adjusted BMI increased 0.2 (0.5) in the placebo group and decreased 0.9 (0.5) in the metformin XR group (P=.03). This difference persisted for 12 to 24 weeks after cessation of treatment. No significant effects of metformin on body composition, abdominal fat, or insulin indices were observed. Conclusion: Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program. Trial Registration: clinicaltrials.gov Identifiers: NCT00209482 and NCT00120146.",
author = "Wilson, {Darrell M.} and Abrams, {Stephanie H.} and Tandy Aye and Lee, {Phillip D.K.} and Carine Lenders and Lustig, {Robert H.} and Osganian, {Stavroula V.} and Feldman, {Henry A.} and Patricia Fechner and Thomas Robinson and Bruce Buckingham and Trudy Esrey and Keniki McNeil and Beatrice Sorensen and Kirsten Wilson and Jeanne Davis and William Klish and Stephanie Abrams and Pam Holt and Cynthia Edwards and Linda Howard and Stephen Gitelman and Marcia Wertz and Jessica Breland and Tania Lihatsh and Anna Haddal and Pinchas Cohen and Sally Shupien and Janet Mooney and Elena Khanukhova and Helene Cohen and George Taylor and Christopher Duggan and Sam Nurko and Carol Sweeney and Katie Zhang and Maggie McCarthy and Michael Wake and Rajna Filip-Dhima and Charles Prober and Karen Urbanek and Alisa Kim and Anita Kelley and Christine Crabtree and Dennis Styne and Michael Gottschalk and Daniel Hale and Heidi Krause-Steinrauf",
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Wilson, DM, Abrams, SH, Aye, T, Lee, PDK, Lenders, C, Lustig, RH, Osganian, SV, Feldman, HA, Fechner, P, Robinson, T, Buckingham, B, Esrey, T, McNeil, K, Sorensen, B, Wilson, K, Davis, J, Klish, W, Abrams, S, Holt, P, Edwards, C, Howard, L, Gitelman, S, Wertz, M, Breland, J, Lihatsh, T, Haddal, A, Cohen, P, Shupien, S, Mooney, J, Khanukhova, E, Cohen, H, Taylor, G, Duggan, C, Nurko, S, Sweeney, C, Zhang, K, McCarthy, M, Wake, M, Filip-Dhima, R, Prober, C, Urbanek, K, Kim, A, Kelley, A, Crabtree, C, Styne, D, Gottschalk, M, Hale, D & Krause-Steinrauf, H 2010, 'Metformin extended release treatment of adolescent obesity: A 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up', Archives of Pediatrics and Adolescent Medicine, vol. 164, no. 2, pp. 116-123. https://doi.org/10.1001/archpediatrics.2009.264

Metformin extended release treatment of adolescent obesity : A 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up. / Wilson, Darrell M.; Abrams, Stephanie H.; Aye, Tandy; Lee, Phillip D.K.; Lenders, Carine; Lustig, Robert H.; Osganian, Stavroula V.; Feldman, Henry A.; Fechner, Patricia; Robinson, Thomas; Buckingham, Bruce; Esrey, Trudy; McNeil, Keniki; Sorensen, Beatrice; Wilson, Kirsten; Davis, Jeanne; Klish, William; Abrams, Stephanie; Holt, Pam; Edwards, Cynthia; Howard, Linda; Gitelman, Stephen; Wertz, Marcia; Breland, Jessica; Lihatsh, Tania; Haddal, Anna; Cohen, Pinchas; Shupien, Sally; Mooney, Janet; Khanukhova, Elena; Cohen, Helene; Taylor, George; Duggan, Christopher; Nurko, Sam; Sweeney, Carol; Zhang, Katie; McCarthy, Maggie; Wake, Michael; Filip-Dhima, Rajna; Prober, Charles; Urbanek, Karen; Kim, Alisa; Kelley, Anita; Crabtree, Christine; Styne, Dennis; Gottschalk, Michael; Hale, Daniel; Krause-Steinrauf, Heidi.

In: Archives of Pediatrics and Adolescent Medicine, Vol. 164, No. 2, 01.02.2010, p. 116-123.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Metformin extended release treatment of adolescent obesity

T2 - A 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up

AU - Wilson, Darrell M.

AU - Abrams, Stephanie H.

AU - Aye, Tandy

AU - Lee, Phillip D.K.

AU - Lenders, Carine

AU - Lustig, Robert H.

AU - Osganian, Stavroula V.

AU - Feldman, Henry A.

AU - Fechner, Patricia

AU - Robinson, Thomas

AU - Buckingham, Bruce

AU - Esrey, Trudy

AU - McNeil, Keniki

AU - Sorensen, Beatrice

AU - Wilson, Kirsten

AU - Davis, Jeanne

AU - Klish, William

AU - Abrams, Stephanie

AU - Holt, Pam

AU - Edwards, Cynthia

AU - Howard, Linda

AU - Gitelman, Stephen

AU - Wertz, Marcia

AU - Breland, Jessica

AU - Lihatsh, Tania

AU - Haddal, Anna

AU - Cohen, Pinchas

AU - Shupien, Sally

AU - Mooney, Janet

AU - Khanukhova, Elena

AU - Cohen, Helene

AU - Taylor, George

AU - Duggan, Christopher

AU - Nurko, Sam

AU - Sweeney, Carol

AU - Zhang, Katie

AU - McCarthy, Maggie

AU - Wake, Michael

AU - Filip-Dhima, Rajna

AU - Prober, Charles

AU - Urbanek, Karen

AU - Kim, Alisa

AU - Kelley, Anita

AU - Crabtree, Christine

AU - Styne, Dennis

AU - Gottschalk, Michael

AU - Hale, Daniel

AU - Krause-Steinrauf, Heidi

PY - 2010/2/1

Y1 - 2010/2/1

N2 - Background: Metformin has been proffered as a therapy for adolescent obesity, although long-term controlled studies have not been reported. Objective: To test the hypothesis that 48 weeks of daily metformin hydrochloride extended release (XR) therapy will reduce body mass index (BMI) in obese adolescents, as compared with placebo. Design: Multicenter, randomized, double-blind, placebocontrolled clinical trial. Setting: The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007. Participants: Obese (BMI≥95th percentile) adolescents (aged 13-18 years) were randomly assigned to the intervention (n=39) or placebo groups. Intervention: Following a 1-month run-in period, subjects following a lifestyle intervention program were randomized 1:1 to 48 weeks' treatment with metformin hydrochloride XR, 2000mgonce daily, or an identical placebo. Subjects were monitored for an additional 48 weeks. Main Outcome Measure: Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo. Results: After 48 weeks, mean (SE) adjusted BMI increased 0.2 (0.5) in the placebo group and decreased 0.9 (0.5) in the metformin XR group (P=.03). This difference persisted for 12 to 24 weeks after cessation of treatment. No significant effects of metformin on body composition, abdominal fat, or insulin indices were observed. Conclusion: Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program. Trial Registration: clinicaltrials.gov Identifiers: NCT00209482 and NCT00120146.

AB - Background: Metformin has been proffered as a therapy for adolescent obesity, although long-term controlled studies have not been reported. Objective: To test the hypothesis that 48 weeks of daily metformin hydrochloride extended release (XR) therapy will reduce body mass index (BMI) in obese adolescents, as compared with placebo. Design: Multicenter, randomized, double-blind, placebocontrolled clinical trial. Setting: The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007. Participants: Obese (BMI≥95th percentile) adolescents (aged 13-18 years) were randomly assigned to the intervention (n=39) or placebo groups. Intervention: Following a 1-month run-in period, subjects following a lifestyle intervention program were randomized 1:1 to 48 weeks' treatment with metformin hydrochloride XR, 2000mgonce daily, or an identical placebo. Subjects were monitored for an additional 48 weeks. Main Outcome Measure: Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo. Results: After 48 weeks, mean (SE) adjusted BMI increased 0.2 (0.5) in the placebo group and decreased 0.9 (0.5) in the metformin XR group (P=.03). This difference persisted for 12 to 24 weeks after cessation of treatment. No significant effects of metformin on body composition, abdominal fat, or insulin indices were observed. Conclusion: Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program. Trial Registration: clinicaltrials.gov Identifiers: NCT00209482 and NCT00120146.

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