Metformin therapy for East Asian women with recent gestational diabetes mellitus and glucose abnormalities: a multicenter, randomized, open-label trial

Authors National Center for Child Health and Development Tokyo Japan -More
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
Links ICTRP
INTERVENTION: The standard lifestyle intervention will include the provision of individual advice on diet and exercise for 24 months. Patients diagnosed with diabetes will be withdrawn. The standard lifestyle intervention will include the provision of individual advice on diet and exercise. Treatment with metformin will be initiated at a dose of 500mg taken orally twice a day, and will be increased to 1500mg daily, unless gastrointestinal symptoms occur. Standard lifestyle intervention plus metformin therapy will continue for 24 months. Patients diagnosed with diabetes will be withdrawn. CONDITION: Women with recent gestational diabetes mellitus (GDM) and glucose abnormalities, including impaired fasting glucose (IFG), or impaired glucose tolerance (IGT), or both (IFG, IGT) postpartum. PRIMARY OUTCOME: Period of progression to type 2 diabetes mellitus SECONDARY OUTCOME: 1.Change in blood glucose and serum insulin levels determined by a 75g oral glucose tolerance test (OGTT); 2.Change in index of insulin sensitivity (Matsuda index) from baseline and at study end (24 months after initiation of therapy, or the final point to be observed); 3.Change in index of insulin resistance (HOMA‐IR)from baseline and at study end (24 months after initiation of therapy, or the final point to be observed); 4.Change in index of beta‐cell function (Disposition index, Insulinogenic index) from baseline and at study end (24 months after initiation of therapy, or the final point to be observed); 5.Change in blood pressure, lipid metabolism, and body weight from baseline; 6.Improvement to normal glucose tolerance; 7.Incidence rate of adverse events INCLUSION CRITERIA: Women who: (1)experienced GDM in a previous singleton pregnancy in the past 5 years. Postpartum metabolic abnormalities determined by a 75g OGTT, inclusive of prior GDM with IFG, IGT, or both (IFG, IGT) postpartum; (2)can respond to the questionnaire in Japanese; (3)are over 20 years of age; (4)have a record of clinical data during pregnancy; (5)own the Maternal and Child Health Handbook.
Epistemonikos ID: 606a86d5595f735c2b80b9afa93b7d775e79b246
First added on: Aug 23, 2024