SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy (SWIFT)
|ClinicalTrials.gov Identifier: NCT01967030|
Recruitment Status : Active, not recruiting
First Posted : October 22, 2013
Last Update Posted : September 10, 2018
|Condition or disease|
|Type 2 Diabetes|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1035 participants|
|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|
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).
Biospecimen Retention: Samples With DNA
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|