This trial is investigating the effects of diet on the microbiome of pregnant women and their connection to developing gestational diabetes mellitus.
- Gestational Diabetes
- Pregnancy Complications
1 Primary · 8 Secondary · Reporting Duration: Up to approximately GA Week 37; up to approximately 12 weeks post birth
4 Treatment Groups
ArmD_Post-diagnosis Gestational Diabetes Control
1 of 4
ArmC_Non- Pregnant Control
1 of 4
ArmA_Random Diet Control
1 of 4
ArmB_Recommended Diet Experimental
1 of 4
65 Total Participants · 4 Treatment Groups
Primary Treatment: Recommended Diet · No Placebo Group · Phase 1
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Age 18 - 45 · Female Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Hasan, Sayyid, Velma Aho, Pedro Pereira, Lars Paulin, Saila B. Koivusalo, Petri Auvinen, and Johan G. Eriksson. 2017. “Gut Microbiome in Gestational Diabetes: A Cross-sectional Study of Mothers and Offspring 5 Years Postpartum”. Acta Obstetricia Et Gynecologica Scandinavica. Wiley. doi:10.1111/aogs.13252.
- Moses, Robert G. 1996. “The Recurrence Rate of Gestational Diabetes in Subsequent Pregnancies”. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.19.12.1348.
- Su, Minglian, Yuanyang Nie, Ruocheng Shao, Shihao Duan, Youhui Jiang, Mingyue Wang, Zhichao Xing, Qun Sun, Xinghui Liu, and Wenming Xu. 2018. “Diversified Gut Microbiota in Newborns of Mothers with Gestational Diabetes Mellitus”. Edited by Gianfranco D. Alpini. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0205695.
- Moses RG. The recurrence rate of gestational diabetes in subsequent pregnancies. Diabetes Care. 1996 Dec;19(12):1348-50. doi: 10.2337/diacare.19.12.1348.
- Nini Fan 2022. "Gestational Diabetes Mellitus (GDM) in Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05265741.
Frequently Asked Questions
How many individuals are enrolled in this investigation?
"Affirmative, the information on clinicaltrials.gov confirms that this medical trial is recruiting participants. This experiment was first posted on February 11th 2022 and its most recent update occurred two weeks later. The study seeks to enroll 65 individuals at a single site." - Anonymous Online Contributor
Are applicants aged 25 or older being considered for this experiment?
"Qualified participants must be between the age of 18 and 45 to partake in this research study." - Anonymous Online Contributor
Has Recommended Diet been endorsed by the FDA?
"Since the evidence is still limited, Recommended Diet has been given a safety rating of 1 on our internal scale. This score reflects that this trial is in its earliest stages and lacks substantial data regarding efficacy and safety." - Anonymous Online Contributor
Are participants currently being sought for this clinical trial?
"The details on clinicaltrials.gov show that the recruitment process for this study is still active, commencing February 11th 2022 and revised February 23rd 2022." - Anonymous Online Contributor
Who qualifies for this medical research experiment?
"This medical trial is looking to enrol 65 individuals, aged 18-45 who have experienced adverse birth outcomes. Furthermore, potential participants need to meet the following criteria: female patients between 18-45 years old; Groups A/B/D must be verified pregnant through a blood test (medical documentation); Subgroups A1 and B1 are expecting mothers in their initial trimester of pregnancy; Subgroups A2 and B2 encompass expectant women during their second stage of gestation; Subgroups A3 and B3 include those that are carrying a child in their final semester of pregnancy; Group D comprises females whose OGTT scores were below par after" - Anonymous Online Contributor