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.
Conditions
Interventions
<
Standard lifestyle intervention alone>
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 Patients diagnosed with diabetes will be withdrawn.
<
Standard lifestyle intervention plus metformin >
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 wi
Sponsors
National Center for Child Health and Development, Tokyo, Japan
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: (1)currently lactating; (2)planning to conceive in the next two years; (3)a history of diabetes and prior use of metformin or insulin to treat diabetes; (4)a history of lactic acidosis; (5)renal impairment (serum creatinine (Cr) level >=1.2mg/dl, including dialysis patients); (6)severe liver dysfunction (serum aspartate transaminase (AST) and/or aminotransferase (ALT) level exceeding more than a threefold increase in normal lab values); (7)cardiac failure, cardiac infarction, pulmonary embolism, a high degree of failure in lung function, and hypoxemia; (8)excessive alcohol intake; (9)malnutrition, or are in a state of starvation or debility, or have pituitary malfunction or adrenal insufficiency; (10)a history of hypersensitivity reaction to metformin or other biguanides; (11)thyroid function that is not controlled by hyperthyroidism (serum free thyroxine (fT4) levels exceed normal lab values within three months); (12)autoantibody-positive status (e.g. GAD, IA-2), or suspected diabetes mellitus associated with a mutation of mitochondrial DNA, maternally inherited diabetes and deafness (MIDD), or MODY (maturity-onset diabetes of the young); (13) not considered eligible to participate in this study by the attending doctor due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Period of progression to type 2 diabetes mellitus | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMaki Kawasaki
National Center for Child Health and Development, Tokyo, Japan Maternal Medicine
Outcome results
None listed