NCT01967030Active, not recruiting
SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1035 (actual)
- First submitted
- 11 Oct 2013
- Start date
- May 2008
- Primary completion date
- Sept 2030
- Lead sponsor
- Kaiser Permanente
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT01967030
What you commit to
- Study type: Observational
- Participants enrolled: 1035
- From May 2008 to the primary completion date, Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Women who fed both breast milk and 7-16 oz of formula (mixed feeding) during the first 4 weeks of life
Who the study is looking for
- 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.
Age in the registry: 20 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaiser Permanente Northern California, Division of Research Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.