Type 2 DiabetesSWIFTNCT01967030
SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy
An observational study of Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 1,035 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- Women who fed both breast milk and 7-16 oz of formula (mixed feeding) during the first 4 weeks of life
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California, Division of Research
Oakland, California, 94612
About this study
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.
Read the detailed description
The SWIFT study recruited women during pregnancy, and enrolled 1,035 women diagnosed with GDM who delivered a singleton, live born infant of at least 35 weeks gestation at a Kaiser Permanente Northern California hospital from 2008 to 2011, and met other study eligibility criteria. Women with recent GDM consented to three in-person research exams with the first exam at 6-9 weeks postpartum (study baseline) and the two follow up research exams continuing annually thereafter for two years post-baseline. SWIFT participants continued to be followed for clinical diagnoses of diabetes via the KPNC electronic health record system during the subsequent years through present. The study enrollment of participants began in late 2008 and ended in December 2011, and in-person follow up exams through 2014. The SWIFT cohort is racially and ethnically diverse (75% minority) with 35% Asian (1/3 South Asian, 1/3 Southeast Asian, 1/3 Chinese), 9% Black, 31% Hispanic, 23% White, and 2% mixed race/Native groups, and includes a longitudinal research Biobank, and research datasets, and clinical electronic health record data for diagnoses of diabetes and other clinical measures.
Each woman provided written informed consent for three in-person exams involving administration of the 2-hour 75 gram Oral Glucose Tolerance Test (OGTT) to reclassify glucose tolerance in women following GDM pregnancy, and numerous other research assessments. At baseline, 21 women were classified with overt diabetes and excluded from follow up, 2 women dropped out at baseline, and 2 women were ineligible. There were 1,010 women with recent GDM and no diabetes at baseline who were followed to evaluate the primary study outcome, the progression to glucose intolerance during the two year follow up period, defined as incident diabetes by American Diabetes Association (ADA) criteria from the 2-hour 75 gram OGTT glucose values, and/or clinical medical diagnosis of diabetes. The annual study follow up exams during the 2 years post-baseline occurred from 2009-2014. The study cohort continues in ongoing follow up for progression to diabetes and subsequent pregnancies via laboratory testing from the Kaiser Permanente electronic health records through present (72% remain KPNC health plan members). A 4th in person research exam is enrolling SWIFT participants in 2022-2024,
The primary exposure for the study is lactation intensity and duration assessed quantitatively using the method by Piper et al. 2001 to estimate a continuous lactation intensity and duration score up to 12 months postpartum. The study assessed infant feeding prospectively from prenatal telephone contacts to assess breastfeeding intention via a standardized method, inpatient hospital delivery records, participant infant feeding diaries, telephone contacts at 1 month postpartum, self-administered monthly mailed surveys (from 3 to 11 months postpartum), and from surveys at the three in-person annual study exams. Data collection during and after pregnancy was also obtained from electronic health records related to perinatal course (e.g., laboratory diagnosis of GDM phenotype severity: 3-hr OGTT z-score and GDM treatment, gestational age at GDM diagnosis, maternal pre-pregnancy BMI, gestational weight gain), medical history, prenatal measures, subsequent pregnancies, and the maternal and newborn outcomes.
Subsequent studies of metabolites preceding progression to overt diabetes after gestational diabetes pregnancy are underway. Investigations are ongoing to measure changes in metabolomics, proteomics and lipidomics at the baseline and follow up exams.
At each of three study exams, trained research staff assessed maternal characteristics (infant feeding, sociodemographics, medical and reproductive history, subsequent pregnancies, medication use, recurrence of GDM, physical activity, dietary intake, depression, and sleep habits/disorders), as well as breastfeeding intensity and duration, infant health, and complementary infant dietary intake using self- and interviewer-administered questionnaires. Trained research staff measured participant anthropometry and body composition via bioelectrical impedance assessment according to standardized research protocols, as well as collected, processed, and stored biospecimens from 2-hour 75 g OGTTs (fasting and 2-h plasma and buffy coat), and administered questionnaires at each in-person exam.
The SWIFT Offspring Study, an ancillary study of mother-infant dyads, conducted three in-person exams from 6-9 weeks, 6 months and 12 months to evaluate infant ponderal growth (weight and length) during the first year of life as well as sleep, infant temperament, dietary intake, skinfold thickness, breastfeeding and formula feeding, and collect saliva specimens in the infants of the SWIFT mothers.
Ongoing surveillance to ascertain new diagnoses of diabetes in the SWIFT cohort occurred both during and after the study period via the KPNC electronic health records from 2009 to 2018. The SWIFT study plans to recontact all 1,033 active participants in 2019 to conduct a fourth in-person exam at 12 years post-baseline from 2022-2024 (delayed due to COVID-19 pandemic). The fourth in-person research exam at 12-years post-baseline will reassess glucose tolerance, anthropometry, body composition and other attributes as described previously. The SWIFT study also utilizes fasting plasma specimens sampled within the early postpartum period to identify metabolites for the early prediction of future progression to type 2 diabetes. Changes in anthropometry, lifestyle behaviors, and risk factors for diabetes will also be assessed at the 12-year post-baseline in-person exam.
- Conditions
- Type 2 Diabetes
- Keywords
- gestational diabetes mellitus, breastfeeding, obesity, type 2 diabetes, lactation, prospective, women, postpartum, incident diabetes, epidemiology, metabolomics, cardiometabolic health
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational, Breast Feeding, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Type 2 Diabetes
Two-hour 75 gram oral glucose tolerance test; fasting plasma and 2-hour post-load plasma samples analyzed for glucose and insulin concentrations.
Measured: baseline to 12 years postpartum
Secondary outcomes (3)
Maternal weight
Body weight
Measured: 2 years postpartum and 12 years post-baseline
Body composition
Tetra polar Bioelectrical impedance to estimate percent body fat
Measured: 2 years postpartum and 12 years post-baseline
Maternal waist circumference
Waist circumference
Measured: 2 years postpartum and 12 years post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startMay 2008
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Erica P Gunderson, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967030
- Sponsor's protocol ID
- CN-04EGund-03-H
- Other IDs
- R01HD050625, R01DK118409-01, R21DK103171, 200-2011-M-39058, R56HL148260
- Acronym
- SWIFT
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2013
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Gunderson EP. Impact of breastfeeding on maternal metabolism: implications for women with gestational diabetes. Curr Diab Rep. 2014 Feb;14(2):460. doi: 10.1007/s11892-013-0460-2.
PubMed 24402327Gunderson EP. The role of lactation in GDM women. Clin Obstet Gynecol. 2013 Dec;56(4):844-52. doi: 10.1097/GRF.0b013e3182a8e067.
PubMed 24100596Gunderson EP, Greenspan LC, Faith MS, Hurston SR, Quesenberry CP Jr; SWIFT Offspring Study Investigators. Breastfeeding and growth during infancy among offspring of mothers with gestational diabetes mellitus: a prospective cohort study. Pediatr Obes. 2018 Aug;13(8):492-504. doi: 10.1111/ijpo.12277. Epub 2018 Apr 24.
PubMed 29691992Batchuluun B, Al Rijjal D, Prentice KJ, Eversley JA, Burdett E, Mohan H, Bhattacharjee A, Gunderson EP, Liu Y, Wheeler MB. Elevated Medium-Chain Acylcarnitines Are Associated With Gestational Diabetes Mellitus and Early Progression to Type 2 Diabetes and Induce Pancreatic beta-Cell Dysfunction. Diabetes. 2018 May;67(5):885-897. doi: 10.2337/db17-1150. Epub 2018 Feb 7.
PubMed 29436377Davis JN, Shearrer GE, Tao W, Hurston SR, Gunderson EP. Dietary variables associated with substantial postpartum weight retention at 1-year among women with GDM pregnancy. BMC Obes. 2017 Aug 3;4:31. doi: 10.1186/s40608-017-0166-0. eCollection 2017.
PubMed 28794888Gunderson EP; Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy Investigators. Lactation and Progression to Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus. Ann Intern Med. 2016 Aug 16;165(4):299-300. doi: 10.7326/L16-0106. No abstract available.
PubMed 27538169Allalou A, Nalla A, Prentice KJ, Liu Y, Zhang M, Dai FF, Ning X, Osborne LR, Cox BJ, Gunderson EP, Wheeler MB. A Predictive Metabolic Signature for the Transition From Gestational Diabetes Mellitus to Type 2 Diabetes. Diabetes. 2016 Sep;65(9):2529-39. doi: 10.2337/db15-1720. Epub 2016 Jun 23.
PubMed 27338739Gunderson EP, Hurston SR, Ning X, Lo JC, Crites Y, Walton D, Dewey KG, Azevedo RA, Young S, Fox G, Elmasian CC, Salvador N, Lum M, Sternfeld B, Quesenberry CP Jr; Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy Investigators. Lactation and Progression to Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus: A Prospective Cohort Study. Ann Intern Med. 2015 Dec 15;163(12):889-98. doi: 10.7326/M15-0807. Epub 2015 Nov 24.
PubMed 26595611Gunderson EP, Hurston SR, Dewey KG, Faith MS, Charvat-Aguilar N, Khoury VC, Nguyen VT, Quesenberry CP Jr. The study of women, infant feeding and type 2 diabetes after GDM pregnancy and growth of their offspring (SWIFT Offspring study): prospective design, methodology and baseline characteristics. BMC Pregnancy Childbirth. 2015 Jul 17;15:150. doi: 10.1186/s12884-015-0587-z.
PubMed 26177722Gunderson EP, Kim C, Quesenberry CP Jr, Marcovina S, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Crites Y, Lo JC, Ning X, Dewey KG. Lactation intensity and fasting plasma lipids, lipoproteins, non-esterified free fatty acids, leptin and adiponectin in postpartum women with recent gestational diabetes mellitus: the SWIFT cohort. Metabolism. 2014 Jul;63(7):941-50. doi: 10.1016/j.metabol.2014.04.006. Epub 2014 Apr 13.
PubMed 24931281Gunderson EP, Crites Y, Chiang V, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Hedderson MM, Quesenberry CP, Lo JC, Ferrara A, Sternfeld B. Influence of breastfeeding during the postpartum oral glucose tolerance test on plasma glucose and insulin. Obstet Gynecol. 2012 Jul;120(1):136-43. doi: 10.1097/AOG.0b013e31825b993d.
PubMed 22914402Gunderson EP, Hedderson MM, Chiang V, Crites Y, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Quesenberry CP, Lo JC, Sternfeld B, Ferrara A, Selby JV. Lactation intensity and postpartum maternal glucose tolerance and insulin resistance in women with recent GDM: the SWIFT cohort. Diabetes Care. 2012 Jan;35(1):50-6. doi: 10.2337/dc11-1409. Epub 2011 Oct 19.
PubMed 22011407Gunderson EP, Matias SL, Hurston SR, Dewey KG, Ferrara A, Quesenberry CP Jr, Lo JC, Sternfeld B, Selby JV. Study of Women, Infant Feeding, and Type 2 diabetes mellitus after GDM pregnancy (SWIFT), a prospective cohort study: methodology and design. BMC Public Health. 2011 Dec 23;11:952. doi: 10.1186/1471-2458-11-952.
PubMed 22196129Gunderson EP, Jaffe MG. Pregnancy and Subsequent Glucose Intolerance in Women of Childbearing Age: Heeding the Early Warning Signs for Primary Prevention of Cardiovascular Disease in Women. JAMA Intern Med. 2017 Dec 1;177(12):1742-1744. doi: 10.1001/jamainternmed.2017.4768. No abstract available.
PubMed 29049465Khan SR, Mohan H, Liu Y, Batchuluun B, Gohil H, Al Rijjal D, Manialawy Y, Cox BJ, Gunderson EP, Wheeler MB. The discovery of novel predictive biomarkers and early-stage pathophysiology for the transition from gestational diabetes to type 2 diabetes. Diabetologia. 2019 Apr;62(4):687-703. doi: 10.1007/s00125-018-4800-2. Epub 2019 Jan 15.
PubMed 30645667
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy
- ClinicalTrials.gov ID
- NCT01967030
- Acronym / sponsor ID
- SWIFT / CN-04EGund-03-H
- Conditions
- Type 2 Diabetes
- Keywords
- gestational diabetes mellitus, breastfeeding, obesity, type 2 diabetes, lactation, prospective, women, postpartum
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- 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
- Study start
- May 2008 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The SWIFT study recruited women during pregnancy, and enrolled 1,035 women diagnosed with GDM who delivered a singleton, live born infant of at least 35 weeks gestation at a Kaiser Permanente Northern California hospital from 2008 to 2011, and met other study eligibility criteria. Women with recent GDM consented to three in-person research exams with the first exam at 6-9 weeks postpartum (study baseline) and the two follow up research exams continuing annually thereafter for two years post-baseline. SWIFT participants continued to be followed for clinical diagnoses of diabetes via the KPNC electronic health record system during the subsequent years through present. The study enrollment of participants began in late 2008 and ended in December 2011, and in-person follow up exams through 2014. The SWIFT cohort is racially and ethnically diverse (75% minority) with 35% Asian (1/3 South Asian, 1/3 Southeast Asian, 1/3 Chinese), 9% Black, 31% Hispanic, 23% White, and 2% mixed race/Native groups, and includes a longitudinal research Biobank, and research datasets, and clinical electronic health record data for diagnoses of diabetes and other clinical measures.
Each woman provided written informed consent for three in-person exams involving administration of the 2-hour 75 gram Oral Glucose Tolerance Test (OGTT) to reclassify glucose tolerance in women following GDM pregnancy, and numerous other research assessments. At baseline, 21 women were classified with overt diabetes and excluded from follow up, 2 women dropped out at baseline, and 2 women were ineligible. There were 1,010 women with recent GDM and no diabetes at baseline who were followed to evaluate the primary study outcome, the progression to glucose intolerance during the two year follow up period, defined as incident diabetes by American Diabetes Association (ADA) criteria from the 2-hour 75 gram OGTT glucose values, and/or clinical medical diagnosis of diabetes. The annual study follow up exams during the 2 years post-baseline occurred from 2009-2014. The study cohort continues in ongoing follow up for progression to diabetes and subsequent pregnancies via laboratory testing from the Kaiser Permanente electronic health records through present (72% remain KPNC health plan members). A 4th in person research exam is enrolling SWIFT participants in 2022-2024,
The primary exposure for the study is lactation intensity and duration assessed quantitatively using the method by Piper et al. 2001 to estimate a continuous lactation intensity and duration score up to 12 months postpartum. The study assessed infant feeding prospectively from prenatal telephone contacts to assess breastfeeding intention via a standardized method, inpatient hospital delivery records, participant infant feeding diaries, telephone contacts at 1 month postpartum, self-administered monthly mailed surveys (from 3 to 11 months postpartum), and from surveys at the three in-person annual study exams. Data collection during and after pregnancy was also obtained from electronic health records related to perinatal course (e.g., laboratory diagnosis of GDM phenotype severity: 3-hr OGTT z-score and GDM treatment, gestational age at GDM diagnosis, maternal pre-pregnancy BMI, gestational weight gain), medical history, prenatal measures, subsequent pregnancies, and the maternal and newborn outcomes.
Subsequent studies of metabolites preceding progression to overt diabetes after gestational diabetes pregnancy are underway. Investigations are ongoing to measure changes in metabolomics, proteomics and lipidomics at the baseline and follow up exams.
At each of three study exams, trained research staff assessed maternal characteristics (infant feeding, sociodemographics, medical and reproductive history, subsequent pregnancies, medication use, recurrence of GDM, physical activity, dietary intake, depression, and sleep habits/disorders), as well as breastfeeding intensity and duration, infant health, and complementary infant dietary intake using self- and interviewer-administered questionnaires. Trained research staff measured participant anthropometry and body composition via bioelectrical impedance assessment according to standardized research protocols, as well as collected, processed, and stored biospecimens from 2-hour 75 g OGTTs (fasting and 2-h plasma and buffy coat), and administered questionnaires at each in-person exam.
The SWIFT Offspring Study, an ancillary study of mother-infant dyads, conducted three in-person exams from 6-9 weeks, 6 months and 12 months to evaluate infant ponderal growth (weight and length) during the first year of life as well as sleep, infant temperament, dietary intake, skinfold thickness, breastfeeding and formula feeding, and collect saliva specimens in the infants of the SWIFT mothers.
Ongoing surveillance to ascertain new diagnoses of diabetes in the SWIFT cohort occurred both during and after the study period via the KPNC electronic health records from 2009 to 2018. The SWIFT study plans to recontact all 1,033 active participants in 2019 to conduct a fourth in-person exam at 12 years post-baseline from 2022-2024 (delayed due to COVID-19 pandemic). The fourth in-person research exam at 12-years post-baseline will reassess glucose tolerance, anthropometry, body composition and other attributes as described previously. The SWIFT study also utilizes fasting plasma specimens sampled within the early postpartum period to identify metabolites for the early prediction of future progression to type 2 diabetes. Changes in anthropometry, lifestyle behaviors, and risk factors for diabetes will also be assessed at the 12-year post-baseline in-person exam.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Women who fed both breast milk and 7-16 oz of formula (mixed feeding) during the first 4 weeks of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident Type 2 Diabetes
Time frame: baseline to 12 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.
3 secondary outcomes
Maternal weight
Time frame: 2 years postpartum and 12 years post-baseline
Body composition
Time frame: 2 years postpartum and 12 years post-baseline
Maternal waist circumference
Time frame: 2 years postpartum and 12 years post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 24402327Gunderson EP. Impact of breastfeeding on maternal metabolism: implications for women with gestational diabetes. Curr Diab Rep. 2014 Feb;14(2):460. doi: 10.1007/s11892-013-0460-2.
- Results publication: PubMed 24100596Gunderson EP. The role of lactation in GDM women. Clin Obstet Gynecol. 2013 Dec;56(4):844-52. doi: 10.1097/GRF.0b013e3182a8e067.
- Results publication: PubMed 29691992Gunderson EP, Greenspan LC, Faith MS, Hurston SR, Quesenberry CP Jr; SWIFT Offspring Study Investigators. Breastfeeding and growth during infancy among offspring of mothers with gestational diabetes mellitus: a prospective cohort study. Pediatr Obes. 2018 Aug;13(8):492-504. doi: 10.1111/ijpo.12277. Epub 2018 Apr 24.
- Results publication: PubMed 29436377Batchuluun B, Al Rijjal D, Prentice KJ, Eversley JA, Burdett E, Mohan H, Bhattacharjee A, Gunderson EP, Liu Y, Wheeler MB. Elevated Medium-Chain Acylcarnitines Are Associated With Gestational Diabetes Mellitus and Early Progression to Type 2 Diabetes and Induce Pancreatic beta-Cell Dysfunction. Diabetes. 2018 May;67(5):885-897. doi: 10.2337/db17-1150. Epub 2018 Feb 7.
- Results publication: PubMed 28794888Davis JN, Shearrer GE, Tao W, Hurston SR, Gunderson EP. Dietary variables associated with substantial postpartum weight retention at 1-year among women with GDM pregnancy. BMC Obes. 2017 Aug 3;4:31. doi: 10.1186/s40608-017-0166-0. eCollection 2017.
- Results publication: PubMed 27538169Gunderson EP; Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy Investigators. Lactation and Progression to Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus. Ann Intern Med. 2016 Aug 16;165(4):299-300. doi: 10.7326/L16-0106. No abstract available.
- Results publication: PubMed 27338739Allalou A, Nalla A, Prentice KJ, Liu Y, Zhang M, Dai FF, Ning X, Osborne LR, Cox BJ, Gunderson EP, Wheeler MB. A Predictive Metabolic Signature for the Transition From Gestational Diabetes Mellitus to Type 2 Diabetes. Diabetes. 2016 Sep;65(9):2529-39. doi: 10.2337/db15-1720. Epub 2016 Jun 23.
- Results publication: PubMed 26595611Gunderson EP, Hurston SR, Ning X, Lo JC, Crites Y, Walton D, Dewey KG, Azevedo RA, Young S, Fox G, Elmasian CC, Salvador N, Lum M, Sternfeld B, Quesenberry CP Jr; Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy Investigators. Lactation and Progression to Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus: A Prospective Cohort Study. Ann Intern Med. 2015 Dec 15;163(12):889-98. doi: 10.7326/M15-0807. Epub 2015 Nov 24.
- Results publication: PubMed 26177722Gunderson EP, Hurston SR, Dewey KG, Faith MS, Charvat-Aguilar N, Khoury VC, Nguyen VT, Quesenberry CP Jr. The study of women, infant feeding and type 2 diabetes after GDM pregnancy and growth of their offspring (SWIFT Offspring study): prospective design, methodology and baseline characteristics. BMC Pregnancy Childbirth. 2015 Jul 17;15:150. doi: 10.1186/s12884-015-0587-z.
- Results publication: PubMed 24931281Gunderson EP, Kim C, Quesenberry CP Jr, Marcovina S, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Crites Y, Lo JC, Ning X, Dewey KG. Lactation intensity and fasting plasma lipids, lipoproteins, non-esterified free fatty acids, leptin and adiponectin in postpartum women with recent gestational diabetes mellitus: the SWIFT cohort. Metabolism. 2014 Jul;63(7):941-50. doi: 10.1016/j.metabol.2014.04.006. Epub 2014 Apr 13.
- Results publication: PubMed 22914402Gunderson EP, Crites Y, Chiang V, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Hedderson MM, Quesenberry CP, Lo JC, Ferrara A, Sternfeld B. Influence of breastfeeding during the postpartum oral glucose tolerance test on plasma glucose and insulin. Obstet Gynecol. 2012 Jul;120(1):136-43. doi: 10.1097/AOG.0b013e31825b993d.
- Results publication: PubMed 22011407Gunderson EP, Hedderson MM, Chiang V, Crites Y, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Quesenberry CP, Lo JC, Sternfeld B, Ferrara A, Selby JV. Lactation intensity and postpartum maternal glucose tolerance and insulin resistance in women with recent GDM: the SWIFT cohort. Diabetes Care. 2012 Jan;35(1):50-6. doi: 10.2337/dc11-1409. Epub 2011 Oct 19.
- Breastfeeding Research conducted at the KPNC, Division of Research, Oakland CALink provided by the sponsor.
- BMJ Summarizes the Primary Findings from the SWIFT Study 2015Link provided by the sponsor.
- SWIFT Study WebsiteLink provided by the sponsor.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica P Gunderson, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Type 2 Diabetes (time frame: baseline to 12 years postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01967030, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.