Metformin therapy for East Asian women with recent gestational diabetes mellitus and glucose abnormalities: a multicenter, randomized, open-label trial
- Conditions
- 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.
- Registration Number
- JPRN-UMIN000018995
- Lead Sponsor
- ational Center for Child Health and Development, Tokyo, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 210
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Period of progression to type 2 diabetes mellitus
- Secondary Outcome Measures
Name Time Method 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