Gestational diabetes mellitus
Conditions
Interventions
Control group:Lifestyle intervention plus continuous metformin intervention group
Intervention group:Lifestyle intervention plus intermittent metformin intervention group
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria: 1. GDM was diagnosed during pregnancy, and prediabetes (impaired fasting glucose and/or impaired glucose tolerance) was diagnosed at 4-12 weeks postpartum: (1) Criteria for GDM diagnosed: if any of the following was met based on 75-g OGTT during 24-28 weeks of gestation: 1) Fasting plasma glucose (FPG) = 5.1 mmol/L; 2) 1-h plasma glucose = 10.0 mmol/L; 3) 2-h plasma glucose (2hPG) = 8.5 mmol/L. (2) Criteria for prediabetes diagnosed: If any of the following was met based on 75-g OGTT at 4-12 weeks postpartum: 1) FPG = 6.1 mmol/L and < 7.0mmol/L, and 2hPG < 7.8 mmol/L; 2) FPG < 7.0mmol/L, and 2hPG = 7.8 mmol/L and < 11.1mmol/L. 2. Women aged 18-45 years. 3. Women participate voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not eligible to participate in this study: 1. Pre-existing diabetes before pregnancy; 2. Diabetes diagnosed at 4-12 weeks postpartum; 3. Active or untreated malignant tumors at the the screening visit, or clinical remission malignancy within 5 years prior to the screening visit; 4. A history of organ transplantation or autoimmune disease requiring long-term use of glucocorticoids or immunosuppressant agents; 5. A history of mental illness and inability to complete follow-up; 6. Serious diseases or physically weak, and inability to complete this study per researcher evaluation; 7. Severe cardiovascular, hepatic, or renal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Newly diagnosed diabetes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of remission to normal glucose regulation from prediabetes;Change in bodyweight from baseline;Change in BMI from baseline;Change in waist circumference from baseline;Change in fasting blood glucose from baseline;Change in 2-hour postprandial blood glucose from baseline;Change in HbA1c from baseline; | — |
Countries
China
Contacts
Public ContactCao Xiaopei
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed