Gestational Diabetes Mellitus
Conditions
Interventions
Diebatic diet group:Diet education for diabetes
Diebatic diet+Grimtab group:Diet education for diabetes+supplement of Multi-bran and high-fiber cereal powder(Grimtab,60g/d)
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
Female
Age
21 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with GDM according to Guidelines for the Diagnosis and Treatment of Gestational Diabetes Mellitus (2022) :At 24-28 weeks of pregnancy, a 75g oral glucose tolerance test (OGTT) is performed on women who were not previously diagnosed with diabetes. GDM is diagnosed if any of the following plasma glucose values are reached or exceeded: fasting: 92 mg/dL (5.1 mmol/L); 1-hour postprandial: 180 mg/dL (10.0 mmol/L); 2-hour postprandial: 153 mg/dL (8.5 mmol/L). (2) Age between 21 and 40 years old (age calculated based on the difference between the screening survey date and the date of birth). (3) Singleton pregnancy. (4) Not currently participating in other research projects. (5) Good memory, mobility, and self-care abilities, possessing a smartphone and using social software. (6) Signing an informed consent form. (7) Planning to deliver at Henan Provincial People's Hospital or the Third Affiliated Hospital of Zhengzhou University.
Exclusion criteria
Exclusion criteria: (1) Pre-pregnancy diagnosis of diabetes (type 1 or type 2) or impaired glucose tolerance. (2) Not diagnosed with diabetes before pregnancy, but during pregnancy, blood glucose levels meet any of the following criteria: a. Fasting plasma glucose (FPG) = 7.0 mmol/L; b. Presence of typical hyperglycemia or symptoms of hyperglycemic crisis, with random blood glucose = 11.1 mmol/L; c. HbA1c = 6.5%. (3) Pregnancy complicated by other medical conditions (such as hypertension, hyperthyroidism, hypothyroidism, etc.). (4) Assisted reproductive technology or multiple pregnancies. (5) Unhealthy lifestyle habits during pregnancy, such as smoking or alcohol consumption. (6) Use of antibiotics within the past 3 months, for a duration of 3 days or more. (7) Use of progesterone to support pregnancy in early pregnancy. (8) Use of glucocorticoids during pregnancy or pre-pregnancy. (9) History of gastrointestinal surgery before pregnancy (e.g., gastric bypass surgery), excluding appendicitis and hernia surgery. (10) History of infectious diseases or systemic infectious diseases. (11) No systematic prenatal examination and routine screening in early pregnancy. (12) Unable to guarantee sufficient time to participate in this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Postprandial blood glucose;IRT;The composition of gut microbiota ;The function of gut microbiota ;The metabolism of gut microbiota ;Serum inflammatory factors;Intestines secrete peptide ; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c%;HOMA-IR;HOMA-IS;Serum lipid;Time in range(TIR);gestational weight gain;Delivery method ;Newborn weight, length;Newborn blood glucose curve;Incidence of admission to the neonatal intensive care unit;OGTT; | — |
Countries
China
Contacts
Public ContactYuan Huijuan
Henan Provincial People's Hospital
Outcome results
None listed