SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy — SWIFT  

Type 2 Diabetes Clinical Trial

Official title: SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy

Status Active, not recruiting

Clinical Trial Summary

The overall goal of the Study of Women, Infant Feeding and Type 2 Diabetes after GDM pregnancy (SWIFT) is to determine the relation of longer and more intensive lactation, as compared to formula feeding, on progression to incident type 2 diabetes mellitus among women within several years following delivery of a GDM pregnancy. The initial study enrolled women with recent GDM at 6 to 9 weeks post-delivery to reclassify oral glucose tolerance and conduct subsequent testing of glucose tolerance to ascertain progression to overt diabetes up to two years later. Research methods were utilized to assess lactation intensity and duration quantitatively and to evaluate incidence rates of diabetes, as well as changes in blood glucose levels, insulin resistance, body weight, waist circumference, and overall adiposity from baseline and up to several years later. SWIFT is a prospective, observational cohort study of 1,035 women recruited during pregnancy who were diagnosed with gestational diabetes mellitus (GDM) via Carpenter and Coustan criteria and enrolled into the research study. We assessed the natural history of progression to prediabetes and type 2 diabetes from early postpartum for a racially and ethnically diverse cohort of women with GDM (75% minority) at high-risk for developing overt diabetes within 5-10 years post-delivery.

Clinical Trial Description

The SWIFT study recruited women during pregnancy, and enrolled 1,035 women diagnosed with GDM who delivered a singleton, live born infant of at least 35 weeks gestation at a Kaiser Permanente Northern California hospital from 2008 to 2011, and met other study eligibility criteria. Women with recent GDM consented to three in-person research exams with the first exam at 6-9 weeks postpartum (study baseline) and the two follow up research exams continuing annually thereafter for two years post-baseline. SWIFT participants continued to be followed for clinical diagnoses of diabetes via the KPNC electronic health record system during the subsequent years through present. The study enrollment of participants began in late 2008 and ended in December 2011, and in-person follow up exams through 2014. The SWIFT cohort is racially and ethnically diverse (75% minority) with 35% Asian (1/3 South Asian, 1/3 Southeast Asian, 1/3 Chinese), 9% Black, 31% Hispanic, 23% White, and 2% mixed race/Native groups, and includes a longitudinal research Biobank, and research datasets, and clinical electronic health record data for diagnoses of diabetes and other clinical measures.

Each woman provided written informed consent for three in-person exams involving administration of the 2-hour 75 gram Oral Glucose Tolerance Test (OGTT) to reclassify glucose tolerance in women following GDM pregnancy, and numerous other research assessments. At baseline, 21 women were classified with overt diabetes and excluded from follow up, 2 women dropped out at baseline, and 2 women were ineligible. There were 1,010 women with recent GDM and no diabetes at baseline who were followed to evaluate the primary study outcome, the progression to glucose intolerance during the two year follow up period, defined as incident diabetes by American Diabetes Association (ADA) criteria from the 2-hour 75 gram OGTT glucose values, and/or clinical medical diagnosis of diabetes. The annual study follow up exams during the 2 years post-baseline occurred from 2009-2014. The study cohort continues in ongoing follow up for progression to diabetes and subsequent pregnancies via laboratory testing from the Kaiser Permanente electronic health records through present (72% remain KPNC health plan members). A 4th in person research exam is enrolling SWIFT participants in 2022-2024,

The primary exposure for the study is lactation intensity and duration assessed quantitatively using the method by Piper et al. 2001 to estimate a continuous lactation intensity and duration score up to 12 months postpartum. The study assessed infant feeding prospectively from prenatal telephone contacts to assess breastfeeding intention via a standardized method, inpatient hospital delivery records, participant infant feeding diaries, telephone contacts at 1 month postpartum, self-administered monthly mailed surveys (from 3 to 11 months postpartum), and from surveys at the three in-person annual study exams. Data collection during and after pregnancy was also obtained from electronic health records related to perinatal course (e.g., laboratory diagnosis of GDM phenotype severity: 3-hr OGTT z-score and GDM treatment, gestational age at GDM diagnosis, maternal pre-pregnancy BMI, gestational weight gain), medical history, prenatal measures, subsequent pregnancies, and the maternal and newborn outcomes.

Subsequent studies of metabolites preceding progression to overt diabetes after gestational diabetes pregnancy are underway. Investigations are ongoing to measure changes in metabolomics, proteomics and lipidomics at the baseline and follow up exams.

At each of three study exams, trained research staff assessed maternal characteristics (infant feeding, sociodemographics, medical and reproductive history, subsequent pregnancies, medication use, recurrence of GDM, physical activity, dietary intake, depression, and sleep habits/disorders), as well as breastfeeding intensity and duration, infant health, and complementary infant dietary intake using self- and interviewer-administered questionnaires. Trained research staff measured participant anthropometry and body composition via bioelectrical impedance assessment according to standardized research protocols, as well as collected, processed, and stored biospecimens from 2-hour 75 g OGTTs (fasting and 2-h plasma and buffy coat), and administered questionnaires at each in-person exam.

The SWIFT Offspring Study, an ancillary study of mother-infant dyads, conducted three in-person exams from 6-9 weeks, 6 months and 12 months to evaluate infant ponderal growth (weight and length) during the first year of life as well as sleep, infant temperament, dietary intake, skinfold thickness, breastfeeding and formula feeding, and collect saliva specimens in the infants of the SWIFT mothers.

Ongoing surveillance to ascertain new diagnoses of diabetes in the SWIFT cohort occurred both during and after the study period via the KPNC electronic health records from 2009 to 2018. The SWIFT study plans to recontact all 1,033 active participants in 2019 to conduct a fourth in-person exam at 12 years post-baseline from 2022-2024 (delayed due to COVID-19 pandemic). The fourth in-person research exam at 12-years post-baseline will reassess glucose tolerance, anthropometry, body composition and other attributes as described previously. The SWIFT study also utilizes fasting plasma specimens sampled within the early postpartum period to identify metabolites for the early prediction of future progression to type 2 diabetes. Changes in anthropometry, lifestyle behaviors, and risk factors for diabetes will also be assessed at the 12-year post-baseline in-person exam. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT01967030
• Study type: Observational
• Source: Kaiser Permanente
• Status: Active, not recruiting
• Start date: May 2008
• Completion date: September 2030