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

June 14, 2018 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200052
        • Recruiting
        • Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine;
        • Contact:
          • Wenjuan Wang, Master
          • Phone Number: 18621823005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: nutritional guidance
routine care (all arms with nutritional guidance per routine care)
Active Comparator: oat grains
90 mg oat, per day.
Dietary supplement: oat grains
90 mg oat, containing 4.05 mg β-glucan
Experimental: oat grains and DHA tablets
90 mg oat and 500 mg DHA oral tablets, per day.
Dietary supplement: oat grains
90 mg oat, containing 4.05 mg β-glucan
Dietary supplement: DHA
500 mg DHA tablets
Other Names:
  • Docosahexaenoic acid
Active Comparator: DHA tablets
500 mg DHA oral tablets, per day.
Dietary supplement: DHA
500 mg DHA tablets
Other Names:
  • Docosahexaenoic acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Yexuan Tao, Doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Zhongcheng Luo, Doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-17-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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