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Master's Dissertation
DOI
10.11606/D.5.2012.tde-25042012-093028
Document
Author
Full name
Cristiane Pavão Spaulonci
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2012
Supervisor
Committee
Francisco, Rossana Pulcineli Vieira (President)
Bittar, Roberto Eduardo
Nascimento, Denis José
Title in Portuguese
Comparação entre a metformina e a insulina no tratamento do diabetes gestacional: ensaio clínico randomizado
Keywords in Portuguese
Diabetes gestacional
Diabetes mellitus
Ensaio clínico controlado e randomizado
Gestação
Metformina
Abstract in Portuguese
Objetivo: Avaliar o controle glicêmico em pacientes que utilizaram metformina ou insulina para tratamento do diabetes gestacional, identificando fatores preditores da necessidade de insulina complementar nas pacientes que tiveram, como terapêutica inicial, a metformina. Método: pacientes com DG que não obtiveram controle glicêmico com dieta e exercícios físicos foram randomizadas para receber metformina (n=46) ou insulina (n=46). Os critérios de inclusão foram: gestação única, realização de dieta e exercícios físicos por período mínimo de uma semana, sem controle glicêmico satisfatório, ausência de fatores de risco para acidose láctica, ausência de anormalidades anatômicas e/ou cromossômicas do produto conceptual. Foram excluídas as gestantes que apresentaram perda de seguimento pré-natal. Resultado: A comparação das médias glicêmicas pré-tratamento medicamentoso não mostrou diferença estatisticamente significativa entre os grupos (p=0,790). Porém, após a introdução dos medicamentos, foram observados médias glicêmicas menores no grupo metformina, ao longo do dia (p=0,020), principalmente, após o jantar (p=0,042). Pacientes que utilizaram metformina tiveram menor ganho de peso (p=0,002) e, também, menor frequência de hipoglicemia neonatal (p=0,032). Doze pacientes do grupo metformina (26,08%) necessitaram de insulina complementar para controle glicêmico. A idade gestacional precoce (odds ratio 0,71, CI95% 0,52-0,97; p=0,032) e a média glicêmica pré-tratamento medicamentoso (odds ratio 1,061, CI95% 1,001-1,124; p=0,046) foram identificadas como preditoras da necessidade de insulina complementar. Conclusão: A metformina foi eficaz em propiciar controle glicêmico adequado, com menor ganho de peso e menor frequência de hipoglicemia neonatal. Foi identificado grupo de pacientes com maior probabilidade de necessitar de complementação com insulina para atingir controle glicêmico
Title in English
A randomized clinical trial comparing metformin and insulin for the treatment of gestational diabetes
Keywords in English
Diabetes mellitus
Gestational diabetes
Metformin
Pregnancy
Randomized clinical trial
Abstract in English
Objective: To evaluate glycemic control in women receiving metformin or insulin for the treatment of gestational diabetes, and to identify factors predicting the need for supplemental insulin in women initially treated with metformin. Methods: Women with gestational diabetes who did not achieve glycemic control with diet and exercise were randomized to receive either metformin (n=46) or insulin (n=46). Criteria for inclusion were singleton pregnancy, diet and exercise for a minimum period of one week without satisfactory glycemic control, absence of risk factors for lactic acidosis, and absence of anatomic and/or chromosome anomalies of the conceptus. Patients who were lost to prenatal follow-up were excluded. Results: Comparison of mean pretreatment glucose levels showed no significant difference between groups (P=.790). However, lower mean glucose levels across the day were observed in the metformin group after introduction of the drug (P=.020), especially after dinner (P=.042). Women using metformin presented less weight gain (P=.002) and a lower frequency of neonatal hypoglycemia (P=.032). Twelve women in the metformin group (26.08%) required supplemental insulin for glycemic control. Early gestational age (OR=0.71, 95%CI: 0.52-0.97; P=.032) and mean pretreatment glucose level (OR=1.061, 95%CI: 1.001-1.124; P=.046) were identified as predictors of insulin need. Conclusion: Metformin was found to provide adequate glycemic controlwith lower mean glucose levels across the day, less weight gain and a lower frequency of neonatal hypoglycemia. Logistic regression analysis showed that gestational age at diagnosis and mean pretreatment glucose level were predictors of the need for supplemental insulin therapy in women initially treated with metformin
 
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Publishing Date
2012-04-27
 
WARNING: The material described below relates to works resulting from this thesis or dissertation. The contents of these works are the author's responsibility.
  • SPAULONCI, CRISTIANE PAVÃO, et al. Randomized trial of metformin vs insulin in the management of gestational diabetes [doi:10.1016/j.ajog.2013.03.022]. American Journal of Obstetrics and Gynecology [online], 2013, vol. 209, p. 34e1-34e7.
  • FRANCISCO, R. P. V., et al. Avaliação da glicemia de jejum no início do acompanhamento pré-natal de diabéticas gestacionais. In XIII Congresso Paulista de Obstetrícia e Ginecologia, São Paulo, 2008. XIII Congresso Paulista de Obstetrícia e Ginecologia., 2008. Resumo.
  • Melhor trabalho científico de Obstetrícia - XIV Congresso Paulista de Obstetrícia e Ginecologia/XV Congresso de G&O da região sudeste - SOGESP
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