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

Not Applicable

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Dietary Supplement: DHA; Dietary Supplement: oat grains

• Registration Number: NCT03569501
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

DHA is a long-chain fatty acid that has been shown to increase insulin sensitivity in basic science studies. Some studies have reported that oat (β-glucan) intake in patients with type 2 diabetes may improve glycaemic control. Evidence is emerging that gut microbiota may play an important role in energy homeostasis and glucose metabolism. This RCT aims to test the hypothesis that DHA and/or oat intake may improve glycemic control in women with gestational diabetes mellitus (GDM), and may impact metabolic health in fetuses/infants as indicated by cord blood leptin level. Changes in microbiota may be linked to these effects.

Growing evidence suggests that epigenetic changes may occur during fetal development in response to an adverse in utero environment, and this may "program" the risk of metabolic syndrome and type 2 diabetes in adulthood. GDM's offspring are programmed to be at substantially elevated risk of metabolic syndrome and type 2 diabetes in adulthood. We will explore whether the intervention may affect epigenetic profile in placental DNA in GDM.

Pregnant women bearing a singleton fetus without any evidence of malformation and with a de novo diagnosis of GDM at 22-28 weeks of gestation will be randomized into four arms: DHA, oat, oat plus DHA, and placebo. We will collect maternal blood and stool specimens on recruitment and 8-weeks post-intervention, cord blood and placenta specimens at delivery. The primary outcomes are cord blood leptin concentration in the baby, and fasting blood glucose at the 8 weeks post-intervention in the mother.

Study Timeline

• Study First Submitted: 2017-01-17
• Study Start: 2017-08-01
• Status Verified: 2018-03
• Study First Submitted QC: 2018-06-14
• Last Update Submitted: 2018-06-14
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Primary Completion: 2018-10-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Han nationality
2. 20-45 years old
3. singleton pregnancy
4. natural conception
5. the pregnant women with de novo diagnosis of gestational diabetes mellitus during 22-28 weeks of pregnancy

Exclusion Criteria

1. Pregnant woman or the biological father has diabetes mellitus (Type I or II)
2. the woman has severe diseases or life threatening conditions such as HIV, cancer, renal failure
3. the fetus has known congenital malformation or genetic defects
4. in-vitro fertilization
5. active hepatitis
6. tuberculosis
7. syphilis
8. drug abuser
9. multiple pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
oat grains and DHA tablets	DHA	90 mg oat and 500 mg DHA oral tablets, per day.
DHA tablets	DHA	500 mg DHA oral tablets, per day.
oat grains	oat grains	90 mg oat, per day.
oat grains and DHA tablets	oat grains	90 mg oat and 500 mg DHA oral tablets, per day.

Primary Outcome Measures

Name	Time	Method
neonatal leptin	at birth/delivery	cord blood leptin concentration

Secondary Outcome Measures

Name	Time	Method
maternal fasting plasma glucose concentration	8 weeks post-intervention	fasting plasma glucose concentration

Trial Locations

Locations (1)

Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China