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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of DHA/Oat on Maternal and Neonatal Metabolic Health in Gestational Diabetes Mellitus

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Dietary Supplement: DHA
* Dietary Supplement: oat grains


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Han nationality 20-45 years old singleton pregnancy natural conception the pregnant women with de novo diagnosis of gestational diabetes mellitus during 22-28 weeks of pregnancy Exclusion Criteria: Pregnant woman or the biological father has diabetes mellitus (Type I or II) the woman has severe diseases or life threatening conditions such as HIV, cancer, renal failure the fetus has known congenital malformation or genetic defects in-vitro fertilization active hepatitis tuberculosis syphilis drug abuser multiple pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: nutritional guidance<br>routine care (all arms with nutritional guidance per routine care) | |
| Active Comparator: oat grains<br>90 mg oat, per day. | Dietary Supplement: oat grains<br>* 90 mg oat, containing 4.05 mg β-glucan<br>|
| Experimental: oat grains and DHA tablets<br>90 mg oat and 500 mg DHA oral tablets, per day. | Dietary Supplement: DHA<br>* 500 mg DHA tablets<br>* Other names: Docosahexaenoic acid;Dietary Supplement: oat grains<br>* 90 mg oat, containing 4.05 mg β-glucan<br>|
| Active Comparator: DHA tablets<br>500 mg DHA oral tablets, per day. | Dietary Supplement: DHA<br>* 500 mg DHA tablets<br>* Other names: Docosahexaenoic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal leptin | cord blood leptin concentration | at birth/delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal fasting plasma glucose concentration | fasting plasma glucose concentration | 8 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newborn, oat, gestational diabetes mellitus, docosahexaenoic acid, glycemic control, intestinal flora, leptin