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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 : September 10, 2018
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
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
The 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 study enrolled women with recent GDM at 6 to 9 weeks post-delivery to classify oral glucose tolerance and evaluate the relation of lactation intensity and duration to persistent changes in blood glucose levels, insulin resistance, and changes in body weight, waist circumference, and adiposity during several years post-baseline. SWIFT is a prospective, observational cohort study of 1,035 women diagnosed with gestational diabetes mellitus (GDM) via Carpenter and Coustan criteria during pregnancy who are at high risk for conversion to prediabetes and type 2 diabetes within 5-10 years post-delivery.

Condition or disease
Type 2 Diabetes

  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
Study Start Date : May 2008
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

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).


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 -70 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 13 Kaiser Permanente Northern California (KPNC) medical facilities throughout the region. Participating field sites for data collection were located within the three primary areas including:

North area: Sacramento, South Sacramento, and Roseville Medical Centers, and 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 enrolled women who 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
  • 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 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
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     History of Changes
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 )
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Keywords provided by Kaiser Permanente:
gestational diabetes mellitus
breastfeeding
obesity
type 2 diabetes
lactation
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