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Choline Supplements for Gestational Diabetes

N/A

Recruiting

Research Sponsored by Maimonides Medical Center

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of birth

Awards & highlights

Study Summary

This trial is testing whether choline supplements can help prevent macrosomia (large fetus) in pregnant women with gestational diabetes.

Who is the study for?

This trial is for pregnant women diagnosed with gestational diabetes before week 28 of pregnancy, who are over 18, speak English or Spanish, and plan to deliver at Maimonides Medical Center. It's only for those with a single baby (singleton pregnancy) and not for those with heart conditions, liver disease, or pre-existing high blood sugar.Check my eligibility

What is being tested?

The study tests if taking choline supplements (470mg/day) can help manage fetal growth in pregnancies affected by gestational diabetes. Women will be randomly assigned to receive either the choline supplement or a placebo starting after the 28th week of pregnancy and continuing for 8 weeks.See study design

What are the potential side effects?

Choline is generally safe at this dose; however, potential side effects may include fishy body odor, vomiting, sweating and salivation more than usual. Since it's being tested in pregnant women here, close monitoring will ensure any unexpected effects on mother or fetus are caught early.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of 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

Birthweight

Secondary outcome measures

Gene expression of glucose transporters

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Choline Supplement GroupActive Control1 Intervention

Choline Supplement 470 mg twice daily for total of 8 weeks.

Group II: Placebo GroupPlacebo Group1 Intervention

Placebo pill twice daily for total of 8 weeks.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Maimonides Medical CenterLead Sponsor

69 Previous Clinical Trials

15,235 Total Patients Enrolled

Frequently Asked Questions

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

Is it possible to become a participant in this clinical experiment?

"To participate in this trial, potential candidates must have been diagnosed with diabetes mellitus and be within the age range of 18 to 50. The investigators are aiming for a sample size of 60 individuals."

Answered by AI

What is the intake capacity for this experiment?

"Affirmative. Information found on clinicaltrials.gov confirms that this study is now enrolling participants, having first been posted on April 1st 2020 and last updated February 22nd 2022. The trial aims to recruit 60 individuals from a single medical facility."

Answered by AI

Are participants of twenty-one years or more being solicited for this inquiry?

"This medical trial is looking for participants aged 18 and above, but below 50 years old."

Answered by AI

Are participants being accepted for the current iteration of this experiment?

"Per information posted on clinicaltrials.gov, this medical experiment is currently recruiting volunteers. The trial was initially uploaded to the website on April 1st 2020 and most recently updated February 22nd 2022."

Answered by AI

Recent research and studies

BmjJournal

Obesity and Pregnancy: Mechanisms of Short Term and Long Term Adverse Consequences for Mother and Child

Catalano, Patrick M, and Kartik Shankar. 2017. “Obesity and Pregnancy: Mechanisms of Short Term and Long Term Adverse Consequences for Mother and Child”. Bmj. BMJ. doi:10.1136/bmj.j1.

Nutrition and Metabolic InsightsJournal

Nutrition During Pregnancy Impacts Offspring's Epigenetic Status—evidence from Human and Animal Studies

Geraghty, Aisling A., Karen L. Lindsay, Goiuri Alberdi, Fionnuala M. McAuliffe, and Eileen R. Gibney. 2015. “Nutrition During Pregnancy Impacts Offspring's Epigenetic Status—evidence from Human and Animal Studies”. Nutrition and Metabolic Insights. SAGE Publications. doi:10.4137/nmi.s29527.

The Journal of Nutritional BiochemistryJournal

Choline Prevents Fetal Overgrowth and Normalizes Placental Fatty Acid and Glucose Metabolism in a Mouse Model of Maternal Obesity

Nam, Juha, Esther Greenwald, Chauntelle Jack-Roberts, Tamara T. Ajeeb, Olga V. Malysheva, Marie A. Caudill, Kathleen Axen, et al.. 2017. “Choline Prevents Fetal Overgrowth and Normalizes Placental Fatty Acid and Glucose Metabolism in a Mouse Model of Maternal Obesity”. The Journal of Nutritional Biochemistry. Elsevier BV. doi:10.1016/j.jnutbio.2017.08.004.

DiabetesJournal