NCT03569501

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 26, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

January 17, 2017

Last Update Submit

June 14, 2018

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

gestational diabetes mellitusoatdocosahexaenoic acidglycemic controlintestinal floranewbornleptin

Outcome Measures

Primary Outcomes (1)

  • neonatal leptin

    cord blood leptin concentration

    at birth/delivery

Secondary Outcomes (1)

  • maternal fasting plasma glucose concentration

    8 weeks post-intervention

Study Arms (4)

nutritional guidance

NO INTERVENTION

routine care (all arms with nutritional guidance per routine care)

oat grains

ACTIVE COMPARATOR

90 mg oat, per day.

Dietary Supplement: oat grains

oat grains and DHA tablets

EXPERIMENTAL

90 mg oat and 500 mg DHA oral tablets, per day.

Dietary Supplement: DHADietary Supplement: oat grains

DHA tablets

ACTIVE COMPARATOR

500 mg DHA oral tablets, per day.

Dietary Supplement: DHA

Interventions

DHADIETARY_SUPPLEMENT

500 mg DHA tablets

Also known as: Docosahexaenoic acid
DHA tabletsoat grains and DHA tablets
oat grainsDIETARY_SUPPLEMENT

90 mg oat, containing 4.05 mg β-glucan

oat grainsoat grains and DHA tablets

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Han nationality
  • years old
  • singleton pregnancy
  • natural conception
  • the pregnant women with de novo diagnosis of gestational diabetes mellitus during 22-28 weeks of pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine;

Shanghai, Shanghai Municipality, 200052, China

RECRUITING

Related Publications (17)

  • Vandorsten JP, Dodson WC, Espeland MA, Grobman WA, Guise JM, Mercer BM, Minkoff HL, Poindexter B, Prosser LA, Sawaya GF, Scott JR, Silver RM, Smith L, Thomas A, Tita AT. NIH consensus development conference: diagnosing gestational diabetes mellitus. NIH Consens State Sci Statements. 2013 Mar 6;29(1):1-31.

    PMID: 23748438BACKGROUND

  • Nicholson JK, Holmes E, Wilson ID. Gut microorganisms, mammalian metabolism and personalized health care. Nat Rev Microbiol. 2005 May;3(5):431-8. doi: 10.1038/nrmicro1152.

    PMID: 15821725BACKGROUND

  • Kau AL, Ahern PP, Griffin NW, Goodman AL, Gordon JI. Human nutrition, the gut microbiome and the immune system. Nature. 2011 Jun 15;474(7351):327-36. doi: 10.1038/nature10213.

    PMID: 21677749BACKGROUND

  • Cani PD, Geurts L, Matamoros S, Plovier H, Duparc T. Glucose metabolism: focus on gut microbiota, the endocannabinoid system and beyond. Diabetes Metab. 2014 Sep;40(4):246-57. doi: 10.1016/j.diabet.2014.02.004. Epub 2014 Mar 14.

    PMID: 24631413BACKGROUND

  • Koren O, Goodrich JK, Cullender TC, Spor A, Laitinen K, Backhed HK, Gonzalez A, Werner JJ, Angenent LT, Knight R, Backhed F, Isolauri E, Salminen S, Ley RE. Host remodeling of the gut microbiome and metabolic changes during pregnancy. Cell. 2012 Aug 3;150(3):470-80. doi: 10.1016/j.cell.2012.07.008.

    PMID: 22863002BACKGROUND

  • Plagemann A. Maternal diabetes and perinatal programming. Early Hum Dev. 2011 Nov;87(11):743-7. doi: 10.1016/j.earlhumdev.2011.08.018. Epub 2011 Sep 23.

    PMID: 21945359BACKGROUND

  • Lehnen H, Zechner U, Haaf T. Epigenetics of gestational diabetes mellitus and offspring health: the time for action is in early stages of life. Mol Hum Reprod. 2013 Jul;19(7):415-22. doi: 10.1093/molehr/gat020. Epub 2013 Mar 20.

    PMID: 23515667BACKGROUND

  • Bouchard L, Hivert MF, Guay SP, St-Pierre J, Perron P, Brisson D. Placental adiponectin gene DNA methylation levels are associated with mothers' blood glucose concentration. Diabetes. 2012 May;61(5):1272-80. doi: 10.2337/db11-1160. Epub 2012 Mar 6.

    PMID: 22396200BACKGROUND

  • El Hajj N, Pliushch G, Schneider E, Dittrich M, Muller T, Korenkov M, Aretz M, Zechner U, Lehnen H, Haaf T. Metabolic programming of MEST DNA methylation by intrauterine exposure to gestational diabetes mellitus. Diabetes. 2013 Apr;62(4):1320-8. doi: 10.2337/db12-0289. Epub 2012 Dec 3.

    PMID: 23209187BACKGROUND

  • Desgagne V, Hivert MF, St-Pierre J, Guay SP, Baillargeon JP, Perron P, Gaudet D, Brisson D, Bouchard L. Epigenetic dysregulation of the IGF system in placenta of newborns exposed to maternal impaired glucose tolerance. Epigenomics. 2014 Apr;6(2):193-207. doi: 10.2217/epi.14.3.

    PMID: 24811788BACKGROUND

  • Laine R, Salminen S, Benno Y, Ouwehand AC. Performance of bifidobacteria in oat-based media. Int J Food Microbiol. 2003 May 25;83(1):105-9. doi: 10.1016/s0168-1605(02)00318-5.

    PMID: 12672596BACKGROUND

  • Zhao JP, Levy E, Fraser WD, Julien P, Delvin E, Montoudis A, Spahis S, Garofalo C, Nuyt AM, Luo ZC. Circulating docosahexaenoic acid levels are associated with fetal insulin sensitivity. PLoS One. 2014 Jan 13;9(1):e85054. doi: 10.1371/journal.pone.0085054. eCollection 2014.

    PMID: 24454790BACKGROUND

  • Lindsay KL, Walsh CA, Brennan L, McAuliffe FM. Probiotics in pregnancy and maternal outcomes: a systematic review. J Matern Fetal Neonatal Med. 2013 May;26(8):772-8. doi: 10.3109/14767058.2012.755166. Epub 2013 Jan 11.

    PMID: 23205866BACKGROUND

  • Lindsay KL, Kennelly M, Culliton M, Smith T, Maguire OC, Shanahan F, Brennan L, McAuliffe FM. Probiotics in obese pregnancy do not reduce maternal fasting glucose: a double-blind, placebo-controlled, randomized trial (Probiotics in Pregnancy Study). Am J Clin Nutr. 2014 Jun;99(6):1432-9. doi: 10.3945/ajcn.113.079723. Epub 2014 Mar 19.

    PMID: 24646819BACKGROUND

  • Shen XL, Zhao T, Zhou Y, Shi X, Zou Y, Zhao G. Effect of Oat beta-Glucan Intake on Glycaemic Control and Insulin Sensitivity of Diabetic Patients: A Meta-Analysis of Randomized Controlled Trials. Nutrients. 2016 Jan 13;8(1):39. doi: 10.3390/nu8010039.

    PMID: 26771637RESULT

  • Lindsay KL, Brennan L, Kennelly MA, Maguire OC, Smith T, Curran S, Coffey M, Foley ME, Hatunic M, Shanahan F, McAuliffe FM. Impact of probiotics in women with gestational diabetes mellitus on metabolic health: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):496.e1-11. doi: 10.1016/j.ajog.2015.02.008. Epub 2015 Feb 14.

    PMID: 25687568RESULT

  • Xu YJ, Wang WJ, Zhang QY, Yang MN, Zhang L, He H, Dong Y, Ouyang F, Gao Y, Zhang J, Zheng T, Luo ZC. Docosahexaenoic acid supplementation in gestational diabetes mellitus and neonatal metabolic health biomarkers. Front Nutr. 2023 Mar 20;10:1089131. doi: 10.3389/fnut.2023.1089131. eCollection 2023.

    PMID: 37020805DERIVED

MeSH Terms

Conditions

Diabetes, GestationalGyrate Atrophy

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesEye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Yexuan Tao, Doctor

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY DIRECTOR

  • Zhongcheng Luo, Doctor

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Juan Wang, Master

CONTACT

18621823005wangwe.njuan@163.com

Dan-Li Zhang, Master

CONTACT

13162215826zhangdanli1232@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

June 26, 2018

Study Start

August 1, 2017

Primary Completion

October 1, 2018

Study Completion

March 1, 2019

Last Updated

June 26, 2018

Record last verified: 2018-03

Locations

CN(1)