Skip to content

Effect of Enteral Nutritional Suspension(TPF-DM)(Kangquanli) combined with medical nutrition therapy on pregnancy outcomes in patients with gestational diabetes mellitus: a randomized controlled trial study

Effect of Enteral Nutritional Suspension(TPF-DM)(Kangquanli) combined with medical nutrition therapy on pregnancy outcomes in patients with gestational diabetes mellitus:a randomized controlled trial study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081814
Enrollment
Unknown
Registered
2024-03-13
Start date
2019-02-18
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Gestational Diabetes Mellitus

Interventions

Intervention with Kangquanli Group:Enteral Nutritional Suspension(TPF-DM)(Kangquanli) combined with medical nutrition therapy
diet group:medical nutrition therapy

Sponsors

Capital Medical University Affiliated Beijing Obstetrics and Gynecology Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Age 18~45, (2) Single pregnancy, (3) gestational week 24-28 when diagnosed with gestational diabetes; (4) Two or three of the three OGTT results exceed the diagnostic criteria (diagnostic criteria for the three OGTT results: fasting blood glucose = 5.1 mmol/L, 1-hour blood glucose = 10.0 mmol/L, 2-hour blood glucose = 8.5 mmol/L L); (5) No history of hypertension, diabetes, hyperlipidemia, hepatitis, nephritis, digestive tract diseases (chronic gastritis, enteritis, gastric ulcer and duodenal ulcer, etc.) and infectious diseases (hepatitis, tuberculosis, etc.)

Exclusion criteria

Exclusion criteria: (1) Multiple pregnancy; (2) with a history of food allergies. (3) with regular smoking, drinking, assisted reproductive technology conception, mental illness who cannot answer the questions correctly or who are unwilling to conduct questionnaires will not be included in this study; (4) with a history of bariatric surgery; (5) Failure to follow dietary recommendations. (6) Threatened abortion

Design outcomes

Primary

MeasureTime frame
fasting glycemia;

Secondary

MeasureTime frame
HbA1c;The use of insulin;HOMA-IR;

Countries

China

Contacts

Public ContactGuanghui Li

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

liguanghui@ccmu.edu.cn+86 131 2472 8821

Outcome results

None listed

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