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

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DHA
oat grains
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring gestational diabetes mellitus, oat, docosahexaenoic acid, glycemic control, intestinal flora, newborn, leptin

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Experimental

Active Comparator

Arm Label

nutritional guidance

oat grains

oat grains and DHA tablets

DHA tablets

Arm Description

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

90 mg oat, per day.

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

500 mg DHA oral tablets, per day.

Outcomes

Primary Outcome Measures

neonatal leptin
cord blood leptin concentration

Secondary Outcome Measures

maternal fasting plasma glucose concentration
fasting plasma glucose concentration

Full Information

First Posted
January 17, 2017
Last Updated
June 14, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03569501
Brief Title
Impact of DHA/Oat on Metabolic Health in Gestational Diabetes Mellitus
Official Title
Influence of DHA/Oat on Maternal and Neonatal Metabolic Health in Gestational Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
Keywords
gestational diabetes mellitus, oat, docosahexaenoic acid, glycemic control, intestinal flora, newborn, leptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nutritional guidance
Arm Type
No Intervention
Arm Description
routine care (all arms with nutritional guidance per routine care)
Arm Title
oat grains
Arm Type
Active Comparator
Arm Description
90 mg oat, per day.
Arm Title
oat grains and DHA tablets
Arm Type
Experimental
Arm Description
90 mg oat and 500 mg DHA oral tablets, per day.
Arm Title
DHA tablets
Arm Type
Active Comparator
Arm Description
500 mg DHA oral tablets, per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA
Other Intervention Name(s)
Docosahexaenoic acid
Intervention Description
500 mg DHA tablets
Intervention Type
Dietary Supplement
Intervention Name(s)
oat grains
Intervention Description
90 mg oat, containing 4.05 mg β-glucan
Primary Outcome Measure Information:
Title
neonatal leptin
Description
cord blood leptin concentration
Time Frame
at birth/delivery
Secondary Outcome Measure Information:
Title
maternal fasting plasma glucose concentration
Description
fasting plasma glucose concentration
Time Frame
8 weeks post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Juan Wang, Master
Phone
18621823005
Email
wangwe.njuan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dan-Li Zhang, Master
Phone
13162215826
Email
zhangdanli1232@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yexuan Tao, Doctor
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhongcheng Luo, Doctor
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine;
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjuan Wang, Master
Phone
18621823005

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23748438
Citation
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.
Results Reference
background
PubMed Identifier
15821725
Citation
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.
Results Reference
background
PubMed Identifier
21677749
Citation
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.
Results Reference
background
PubMed Identifier
24631413
Citation
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.
Results Reference
background
PubMed Identifier
22863002
Citation
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.
Results Reference
background
PubMed Identifier
21945359
Citation
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.
Results Reference
background
PubMed Identifier
23515667
Citation
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.
Results Reference
background
PubMed Identifier
22396200
Citation
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.
Results Reference
background
PubMed Identifier
23209187
Citation
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.
Results Reference
background
PubMed Identifier
24811788
Citation
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.
Results Reference
background
PubMed Identifier
12672596
Citation
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.
Results Reference
background
PubMed Identifier
24454790
Citation
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.
Results Reference
background
PubMed Identifier
23205866
Citation
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.
Results Reference
background
PubMed Identifier
24646819
Citation
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.
Results Reference
background
PubMed Identifier
26771637
Citation
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.
Results Reference
result
PubMed Identifier
25687568
Citation
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.
Results Reference
result

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

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