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
|Condition or disease|
|Type 2 Diabetes|
|Study Type :||Observational|
|Actual Enrollment :||1035 participants|
|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|
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.
- 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.
- 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
- 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
Biospecimen Retention: Samples With DNA
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
|United States, California|
|Kaiser Permanente Northern California, Division of Research|
|Oakland, California, United States, 94612|
|Principal Investigator:||Erica P Gunderson, PhD||Kaiser Permanente|