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Impact of DHA/Oat on Metabolic Health in Gestational Diabetes Mellitus

NCT03569501 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-06-26

No results posted yet for this study

Summary

The randomized controlled trial (RCT) recruits pregnant women with de novo diagnosis of gestational diabetes. Women bearing a singleton pregnancy are randomized into four arms: DHA, oat, oat plus DHA, and placebo. The primary outcomes are cord blood leptin concentration in the newborns and maternal fasting glucose levels at 8 weeks post-intervention.

Conditions

  • Gestational Diabetes Mellitus in Pregnancy

Interventions

DIETARY_SUPPLEMENT

DHA

500 mg DHA tablets

DIETARY_SUPPLEMENT

oat grains

90 mg oat, containing 4.05 mg β-glucan

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Yexuan Tao, Doctor · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  • Zhongcheng Luo, Doctor · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-10-01
Completion
2019-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569501 on ClinicalTrials.gov