Summary of Study ST001948

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench,, where it has been assigned Project ID PR001235. The data can be accessed directly via it's Project DOI: 10.21228/M82T49 This work is supported by NIH grant, U2C- DK119886.


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Study IDST001948
Study TitleMetabolites Associated with Gestational Diabetes in Plasma
Study TypeCase:Control ancillary analysis of RCT
Study SummaryGestational diabetes mellitus (GDM) significantly increases maternal and fetal health risks, but factors predictive of GDM are poorly understood. Plasma metabolomics analyses were conducted in early pregnancy to identify potential biomarkers for early prediction of Gestational Diabetes Mellitus (GDM). Sixty-eight pregnant women with overweight/obesity from a clinical trial of a lifestyle intervention were included. Participants who developed GDM (n=34; GDM group) were matched on treatment group, age, body mass index, and ethnicity with those who did not develop GDM (n=34; Non-GDM group). Blood draws were completed early in pregnancy (10-16 weeks). Plasma samples were analyzed by UPLC-MS using three metabolomics assays.
California Polytechnic State University
DepartmentFood Science and Nutrition
LaboratoryCal Poly Metabolomics Service Center
Last NameLa Frano
First NameMichael
Submit Date2021-10-13
Num Groups2
Total Subjects68
Num Females68
Raw Data AvailableYes
Raw Data File Type(s)mzML
Analysis Type DetailLC-MS
Release Date2021-11-04
Release Version1
Michael La Frano Michael La Frano application/zip

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Treatment ID:TR002038
Treatment Summary:This was a secondary analysis using samples from the Healthy Beginnings/Comienzos Saludables Study, a randomized clinical trial (RCT) that is part of the Lifestyle Interventions for Expectant Moms (LIFE-Moms) Consortium (Phelan et al., 2018). This RCT focused on the outcomes of behavior lifestyle change on weight gain during gestation. Samples were acquired from two study sites: California Polytechnic State University, San Luis Obispo, California and Miriam Hospital with Women and Infants Hospital in Providence, Rhode Island. This trial was registered as NCT01545934. Eligibility consisted of being 9-16 weeks gestational age, BMI (in kg/m2) ≥ 25 upon study entry height and weight, English or Spanish speaking, age ≥ 18 years old, and singleton pregnancy. Participants were excluded if glycated hemoglobin ≥ 6.5, reported major health diseases, substance abuse, undergoing treatment for serious psychological disorders, had contradictions to aerobic exercise, or who had repeated no-shows or loss of contact during screening. Participants were randomly assigned to two different intervention methods. Group one received enhanced usual care, which represented the control group. Group two had a multi-component lifestyle intervention, which included diet, exercise, and behavioral change. Data was collected throughout pregnancy, including blood samples, diet assessment, and clinic measured GDM diagnosis. Blood samples were taken between gestational weeks 10-16. Since the multi-component lifestyle intervention showed no statistically significant effect on GDM occurrence (p=0.7) (Phelan et al., 2018), the samples used for this secondary analysis are from both the control and treatment groups. There were a total of 34 GDM cases that were collected from the California (n=13) and Rhode Island (n=21) study sites. Samples for 34 GDM cases were matched to 34 healthy controls prior to metabolomics analysis based on age, study entry body mass index (BMI), ethnicity, study site, and treatment. The two groups did not differ in weight gain from entry to 26 weeks.
Treatment Protocol Filename:La_Frano_Treatment_Protocol_v1.pdf