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Recommended Diet for Gestational Diabetes

Phase 1

Recruiting

Led By Jeanmaire Molina, PhD

Research Sponsored by Long Island University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women between the age of 18-45 Groups A and B have to be confirmed pregnant by blood test (confirmed by medical records) Subgroups A1 and B1 are pregnant women in their first trimester Subgroups A2 and B2 are pregnant women in their second trimester Subgroups A3 and B3 are pregnant women in their third trimester

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately ga week 37; up to approximately 12 weeks post birth

Awards & highlights

Study Summary

This trial is investigating the effects of diet on the microbiome of pregnant women and their connection to developing gestational diabetes mellitus.

Eligible Conditions

Gestational Diabetes
Pregnancy Complications

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately ga week 37; up to approximately 12 weeks post birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately ga week 37; up to approximately 12 weeks post birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately ga week 37; up to approximately 12 weeks post birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy

Secondary outcome measures

Gestational age at Delivery

Gestational age at First GDM

Gestational age at First Preeclampsia

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: ArmB_Recommended Diet ExperimentalExperimental Treatment1 Intervention

This group is composed of pregnant women divided into 3 subgroups, one of each trimester. This arm will be required to provide 2 fecal samples. One at the start of recruitment, and one at the end of a 4-week period. Their diet will be altered and they will received pre-selected food items to consume during this period. The Recommended Diet is designed by a Registered Dietician to provide caloric and nutritional intake

Group II: ArmD_Post-diagnosis Gestational Diabetes ControlActive Control1 Intervention

This group is composed of pregnant women diagnosed with GDM in their current pregnancy through Oral Glucose Tolerance Test. This arm will be required to provide 1 fecal sample. It will be used as comparison of the microbiome of GDM women.

Group III: ArmC_Non- Pregnant ControlActive Control1 Intervention

This group is composed of non-pregnant women. This arm will be required to provide 1 fecal sample. It will be used as a baseline for comparison of the microbiome

Group IV: ArmA_Random Diet ControlActive Control1 Intervention

This group is composed of pregnant women divided into 3 subgroups, one of each trimester. This arm will be required to provide 2 fecal samples. One at the start of recruitment, and one at the end of a 4-week period where they log the food items they consume. Their diet will not be altered as they are required to log their regular diet.

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Long Island UniversityLead Sponsor

8 Previous Clinical Trials

504 Total Patients Enrolled

BROOKLYN INNOSEQ INC.UNKNOWN

Joseph Morin, PhDStudy ChairLong Island University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Recent research and studies

Acta Obstetricia et Gynecologica ScandinavicaJournal

Gut Microbiome in Gestational Diabetes: A Cross-sectional Study of Mothers and Offspring 5 Years Postpartum

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.

Diabetes CareJournal

The Recurrence Rate of Gestational Diabetes in Subsequent Pregnancies

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.

Plos OneJournal

Diversified Gut Microbiota in Newborns of Mothers with Gestational Diabetes Mellitus

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.

clinicaltrials.govStudy