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Efficacy evaluation of medical nutrition therapy combined with insulin or insulin and metformin for gestational diabetes mellitus: a multicenter open-label clinical trial

Efficacy and safety evaluation of different interventions on gestational diabetes mellitus - Sub-study 2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038141
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-09-09
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Interventions

Routine group:General nutrition-guided advise
Quantitative group:quantitative dietary management
Food group:Quantitative dietary management combined supplementary food

Sponsors

Shengjing Hospital Affiliated to China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Gestational diabetes mellitus who is using insulin or insulin combined with metformin to control blood glucose 1. Patients aged 20-45 years old; 2. Patients with body mass index (BMI) above 24.0 kg / m2; 3. Singleton pregnant women of 12-28 weeks gestation; 4. At present, the number of insulin injections per day was more than 2 times or insulin pump was used, and the daily dose was more than the body weight before pregnancy (kg) x 0.5; 5. Patients who can understand the purpose of the clinical trial voluntarily participate and sign the informed consent form; 6. Those who can follow the insulin treatment plan and medical nutrition guidance decided by the researcher; 7. Those who are willing and able to use blood glucose meter to detect fingertip blood glucose and upload blood glucose data using mobile app as required.

Exclusion criteria

Exclusion criteria: 1. Patients who are known to be allergic to insulin, insulin analogues or ingredients in their preparations; 2. In the study of gestational dominant diabetes mellitus, the cases that doctors think may be type 1 diabetes mellitus; 3. The patients whose ALT and / or ast were more than 2.5 times of the upper limit of normal value; 4. Patients with EGFR = + 2 in routine urine examination; 5. Patients who were taking antihypertensive drugs at the time of enrollment; or systolic blood pressure >= 140mmHg and / or diastolic blood pressure >= 90mmHg; hypertension beyond control after treatment was defined as systolic blood pressure >= 140mmHg and / or diastolic blood pressure >= 90mmHg; 6. The subjects who were conceived by in vitro fertilization and embryo transfer (IVF); 7. Subjects with previous history of premature delivery (delivery before 37 weeks of gestation); or abortion in late pregnancy; placenta previa or cervical shortening receiving cerclage; and; 8. Patients who are taking glucocorticoid and heparin have SLE and anticardiolipin antibody syndrome 9. Patients with diseases related to glucose metabolism, such as hyperthyroidism, clinical hypothyroidism and steroid diabetes mellitus; 10. The study doctor judged that the patient's compliance was poor and could not complete the study according to the requirements, or other reasons were not suitable for participation.

Design outcomes

Primary

MeasureTime frame
Pregnancy outcome;

Secondary

MeasureTime frame
Blood glucose related indexes;Dose of insulin;Incidence of preeclampsia;Indexes of metabolism;

Countries

China

Contacts

Public ContactPing Li

Shengjing Hospital Affiliated to China Medical University

s6800@qq.com+86 18940255673

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026