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

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ClinicalTrials.gov Identifier: NCT01967030
Recruitment Status : Active, not recruiting
First Posted : October 22, 2013
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
W.K. Kellogg Foundation
Centers for Disease Control and Prevention
National Heart, Lung, and Blood Institute (NHLBI)
University of Toronto
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date October 11, 2013
First Posted Date October 22, 2013
Last Update Posted Date June 4, 2020
Actual Study Start Date May 2008
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2018)
Incident Type 2 Diabetes [ Time Frame: baseline to 10 years postpartum ]
Two-hour 75 gram oral glucose tolerance test; fasting plasma and 2-hour post-load plasma samples analyzed for glucose and insulin concentrations.
Original Primary Outcome Measures
 (submitted: October 17, 2013)
Incident Type 2 Diabetes [ Time Frame: 2 years postpartum ]
Two-hour 75 gram oral glucose tolerance test; fasting plasma and 2-hour post-load plasma samples analyzed for glucose and insulin concentrations.
Change History
Current Secondary Outcome Measures
 (submitted: October 17, 2013)
  • Maternal weight [ Time Frame: 2 years postpartum ]
    Body weight
  • Body composition [ Time Frame: 2 years postpartum ]
    Tetra polar Bioelectrical impedance to estimate percent body fat
  • Maternal waist circumference [ Time Frame: 2 years postpartum ]
    Waist circumference
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 1, 2020)
  • Insulin Resistance Index [ Time Frame: 2 years postpartum ]
    Fasting plasma and 2 hour post-load plasma assayed for concentrations of glucose and insulin. These measures will be used to calculate homeostatic model assessment of insulin resistance (HOMA-IR).
  • Insulin secretion Index [ Time Frame: 2 years postpartum ]
    Fasting plasma and 2 hour post-load plasma assayed for concentrations of glucose and insulin. These measures will be used to calculate the homeostatic model assessment of insulin secretion (HOMA-ß).
  • Metabolite profiles [ Time Frame: Up to 10 years post-baseline ]
    New Ancillary Study utilizes stored fasting plasmas samples from the 3 in-person research exams in the cohort, and newly collected plasma from the 10-year follow up to measure a panel of 183 targeted metabolites related to type 2 diabetes, and 1000 lipid metabolites using Mass Spectroscopy quantitative methodology. The metabolites will be measured using a panel developed by Metabolon, Inc. These metabolites will be used to identify a signature to predict progression to type 2 diabetes after Gestational diabetes pregnancy
Original Other Pre-specified Outcome Measures
 (submitted: October 17, 2013)
  • Insulin Resistance Index [ Time Frame: 2 years postpartum ]
    Fasting plasma and 2 hour post-load plasma assayed for concentrations of glucose and insulin. These measures will be used to calculate homeostatic model assessment of insulin resistance (HOMA-IR).
  • Insulin secretion Index [ Time Frame: 2 years postpartum ]
    Fasting plasma and 2 hour post-load plasma assayed for concentrations of glucose and insulin. These measures will be used to calculate the homeostatic model assessment of insulin secretion (HOMA-ß).
 
Descriptive Information
Brief Title SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy
Official Title SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy
Brief 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.
Detailed 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, 9% Black, 31% Hispanic, 23% White, and 2% other race groups, and includes a longitudinal Biobank, and research datasets.

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 classify glucose tolerance in women following GDM pregnancy and numerous other assessments. At baseline, 21 women were classified with diabetes and excluded from follow up, 2 women dropped out, 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.

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.

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 10 years post-baseline from 2020-2024. The fourth in-person research exam at 10-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 10-year post-baseline in-person exam.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
We collected fasting and 2-hour plasma specimens during each Oral Glucose Tolerance Test (OGTT). The EDTA treated plasma specimens and buffy coats are stored in cryovials at -80 degrees Centrigrade in low temperature freezers.
Sampling Method Non-Probability Sample
Study Population

SWIFT participants were recruited from Kaiser Permanente Northern California (KPNC) Region medical centers. Participating research field sites for the in-person research exams were located within the three primary areas:

North area: Medical Centers in Sacramento, South Sacramento, and Roseville, and the Rancho Cordova, Elk Grove, Point West, and Folsom Medical Offices; East area: Division of Research (DOR) Research Clinic (Oakland), Hayward Medical Center and Fremont Medical Offices and Richmond Medical Center; South area: Santa Clara, and San Jose Medical Centers.

The prospective cohort of women with GDM received prenatal care and delivered a singleton, live born infant of 35 weeks gestation or longer at a Kaiser Permanente hospital between July 2008 and October 2011.

Condition Type 2 Diabetes
Intervention Not Provided
Study Groups/Cohorts Women with recent GDM pregnancy
The study cohort includes women who had gestational diabetes mellitus (GDM) in their index pregnancy for study enrollment. There are two pre-defined groups: 1) women who breastfeed intensively during the first 4 months postpartum, and 2) women who mostly fed formula during the first 4 months postpartum. The study enrolled women into these pre-defined groups, but some women transitioned into mixed feeding groups after enrollment.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 17, 2013)
1035
Original Actual Enrollment Same as current
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age 20 to 45 years at delivery
  • received prenatal care in Kaiser Permanente Northern California (KPNC) health care system
  • Gestational Diabetes (GDM) pregnancy diagnosed using the 3-hour 100 g OGTT by Carpenter and Coustan criteria
  • delivered a singleton, live birth >= 35 weeks gestation
  • no pre-existing diabetes or other serious medical conditions prior to index GDM pregnancy
  • no diabetes diagnosis (2-hour 75 gram OGTT) at 6 to 9 weeks postpartum for the index GDM pregnancy
  • no use of thyroid medications, steroids, or other medications affecting glucose tolerance
  • not planning to move from the northern California area within the subsequent 24 months
  • not planning another pregnancy within the next two years
  • Two infant feeding groups: women who did not lactate or did so for less than 3 weeks, OR women who provided no supplemental milk feeds at 2-4 weeks and planned to continue intensive lactation defined as <= 1 formula supplement (6 oz/day) from 6-9 weeks until 4 months or more postpartum.

Exclusion criteria:

  • Women who fed both breast milk and 7-16 oz of formula (mixed feeding) during the first 4 weeks of life
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01967030
Other Study ID Numbers CN-04EGund-03-H
R01HD050625 ( U.S. NIH Grant/Contract )
R01DK118409-01 ( U.S. NIH Grant/Contract )
R21DK103171 ( U.S. NIH Grant/Contract )
200-2011-M-39058 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
R56HL148260 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kaiser Permanente
Study Sponsor Kaiser Permanente
Collaborators
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • American Diabetes Association
  • W.K. Kellogg Foundation
  • Centers for Disease Control and Prevention
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Toronto
Investigators
Principal Investigator: Erica P Gunderson, PhD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date April 2020