Last updated: March 12, 2024
Sponsor: Capital Medical University
Overall Status: Completed
Phase
N/A
Condition
Diabetes Prevention
Obesity
Diabetes And Hypertension
Treatment
Medical Nutrition Therpay
Enteral Nutrition Suspension (TFP-DM)
Clinical Study ID
NCT03957603
2017-KY-061-01
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Gestational age between 24 and 28 weeks of gestation
- Age >= 18 years
- Singleton pregnancy
- Two of three or three results of the oral glucose tolerance test (OGTT) are above thediagnostic criteria. (The diagnostic criteria for three results of OGTT: Fastingplasma glucose ≥ 5.1mmol/L, 1-hour OGTT plasma glucose ≥ 10.0mmol/L, 2-hour OGTTplasma glucose ≥ 8.5mmol/L)
Exclusion
Exclusion Criteria:
- History of prenatal hypertension, diabetes, hyperlipidemias, liver disease, kidneydisease, digestive tract disease and infectious disease (hepatitis, tuberculosis etc.)
- Gestational weeks < 24 or > 28
- Age < 18 years or Age > 45 years
- Multiple pregnancy
- Food allergic history
- Regular smoking, drinking alcohol
- Patients with the history of using the assisted reproductive technology
- Patients with psychiatric disorders that prevents correctly answer the questions
- Patients who are unable to answer the questionnaire questions
- Bariatric surgery history
- Non-adherence of dietary and lifestyle recommendation
- Threatened abortion
Study Design
Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Medical Nutrition Therpay
Phase:
Study Start date:
May 16, 2019
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, 100026
ChinaSite Not Available
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