Gestational Diabetes Mellitus in PregnancyNCT03569501
Impact of DHA/Oat on Metabolic Health in Gestational Diabetes Mellitus
A study testing DHA and oat grains in people with Gestational Diabetes Mellitus in Pregnancy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- DHA and oat grains
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- syphilis
- drug abuser
- multiple pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine;
Shanghai, Shanghai Municipality, 200052
Wenjuan Wang, Master, 18621823005
About this study
Official title: 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.
Read the 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.
- Being tested
- DHA, oat grains
- Keywords
- gestational diabetes mellitus, oat, docosahexaenoic acid, glycemic control, intestinal flora, newborn, leptin
- Medical subject headings
- Diabetes, Gestational, Gyrate Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADietary supplement
Also called Docosahexaenoic acid
500 mg DHA tablets
oat grainsDietary supplement
90 mg oat, containing 4.05 mg β-glucan
| Study group | Role | What they receive |
|---|---|---|
| nutritional guidance | No intervention | routine care (all arms with nutritional guidance per routine care) |
| oat grains | Active comparator | 90 mg oat, per day. Receives: Dietary Supplement: oat grains |
| oat grains and DHA tablets | Experimental | 90 mg oat and 500 mg DHA oral tablets, per day. Receives: Dietary Supplement: DHA; Dietary Supplement: oat grains |
| DHA tablets | Active comparator | 500 mg DHA oral tablets, per day. Receives: Dietary Supplement: DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal leptin
cord blood leptin concentration
Measured: at birth/delivery
Secondary outcomes (1)
maternal fasting plasma glucose concentration
fasting plasma glucose concentration
Measured: 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Aug 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yexuan Tao, Doctor, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineZhongcheng Luo, Doctor, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569501
- Sponsor's protocol ID
- XH-17-002
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23748438Nicholson 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.
PubMed 15821725Kau 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.
PubMed 21677749Cani 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.
PubMed 24631413Koren 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.
PubMed 22863002Plagemann 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.
PubMed 21945359Lehnen 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.
PubMed 23515667Bouchard 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.
PubMed 22396200El 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.
PubMed 23209187Desgagne 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.
PubMed 24811788Laine 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.
PubMed 12672596Zhao 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.
PubMed 24454790Lindsay 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.
PubMed 23205866Lindsay 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.
PubMed 24646819Shen 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.
PubMed 26771637
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of DHA/Oat on Maternal and Neonatal Metabolic Health in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03569501
- Acronym / sponsor ID
- XH-17-002
- Keywords
- gestational diabetes mellitus, oat, docosahexaenoic acid, glycemic control, intestinal flora, newborn, leptin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nutritional guidance | No intervention | –routine care (all arms with nutritional guidance per routine care) |
| oat grains | Active comparator | Dietary Supplement: oat grains90 mg oat, per day. |
| oat grains and DHA tablets | Experimental | Dietary Supplement: DHA, Dietary Supplement: oat grains90 mg oat and 500 mg DHA oral tablets, per day. |
| DHA tablets | Active comparator | Dietary Supplement: DHA500 mg DHA oral tablets, per day. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHAAlso: Docosahexaenoic acid500 mg DHA tablets | Dietary supplement | DHA tablets, oat grains and DHA tablets |
| oat grains90 mg oat, containing 4.05 mg β-glucan | Dietary supplement | oat grains, oat grains and DHA tablets |
Primary outcome
neonatal leptin
Time frame: at birth/delivery
cord blood leptin concentration
1 secondary outcome
maternal fasting plasma glucose concentration
Time frame: 8 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 23748438Vandorsten 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.
- Background: PubMed 15821725Nicholson 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.
- Background: PubMed 21677749Kau 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.
- Background: PubMed 24631413Cani 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.
- Background: PubMed 22863002Koren 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.
- Background: PubMed 21945359Plagemann 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.
- Background: PubMed 23515667Lehnen 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.
- Background: PubMed 22396200Bouchard 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.
- Background: PubMed 23209187El 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.
- Background: PubMed 24811788Desgagne 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.
- Background: PubMed 12672596Laine 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.
- Background: PubMed 24454790Zhao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yexuan Tao, Doctor study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Zhongcheng Luo, Doctor principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA and oat grains in people with Gestational Diabetes Mellitus in Pregnancy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Juan Wang, Master (18621823005, wangwe.njuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal leptin (time frame: at birth/delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569501, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.