Impact of DHA/Oat on Metabolic Health in Gestational Diabetes Mellitus
NCT ID: NCT03569501
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-08-01
2019-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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nutritional guidance
routine care (all arms with nutritional guidance per routine care)
No interventions assigned to this group
oat grains
90 mg oat, per day.
oat grains
90 mg oat, containing 4.05 mg β-glucan
oat grains and DHA tablets
90 mg oat and 500 mg DHA oral tablets, per day.
DHA
500 mg DHA tablets
oat grains
90 mg oat, containing 4.05 mg β-glucan
DHA tablets
500 mg DHA oral tablets, per day.
DHA
500 mg DHA tablets
Interventions
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DHA
500 mg DHA tablets
oat grains
90 mg oat, containing 4.05 mg β-glucan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
45 Years
FEMALE
Yes
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Yexuan Tao, Doctor
Role: STUDY_DIRECTOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Zhongcheng Luo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine;
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wenjuan Wang, Master
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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XH-17-002
Identifier Type: -
Identifier Source: org_study_id
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