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Trial record 1 of 1 for:    SWIFT | Breastfeeding | United States
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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

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.

Condition or disease
Type 2 Diabetes

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 1035 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy
Actual Study Start Date : May 2008
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Maternal weight [ Time Frame: 2 years postpartum ]
    Body weight

  2. Body composition [ Time Frame: 2 years postpartum ]
    Tetra polar Bioelectrical impedance to estimate percent body fat

  3. Maternal waist circumference [ Time Frame: 2 years postpartum ]
    Waist circumference


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967030


Locations
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United States, California
Kaiser Permanente Northern California, Division of Research
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
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
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Principal Investigator: Erica P Gunderson, PhD Kaiser Permanente
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: 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 )
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: April 2020
Keywords provided by Kaiser Permanente:
breastfeeding
lactation
gestational diabetes mellitus
obesity
type 2 diabetes
prospective
women
postpartum
incident diabetes
epidemiology
metabolomics
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases