SWIFT: Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy

NCT01967030 | Active Not Recruiting

• 6 other identifiers: CN-04EGund-03-HR01HD050625R01DK118409-01R21DK103171200-2011-M-39058R56HL148260
• Study Type: observational
• Target: 1,035
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes

Keywords

gestational diabetes mellitus; breastfeeding; obesity; type 2 diabetes; lactation; prospective; women; postpartum; incident diabetes; epidemiology; metabolomics; cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to 12 years postpartum

Secondary Outcomes (3)

• Maternal weight

  2 years postpartum and 12 years post-baseline

• Body composition

  2 years postpartum and 12 years post-baseline

• Maternal waist circumference

  2 years postpartum and 12 years post-baseline

Other Outcomes (3)

• Insulin Resistance Index

  2 years postpartum and 12 years post-baseline

• Insulin secretion Index

  2 years postpartum and 12 years post-baseline

• Metabolite profiles

  Up to 12 years post-baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Women who fed both breast milk and 7-16 oz of formula (mixed feeding) during the first 4 weeks of life

Sponsors & Collaborators

• Kaiser Permanente: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• American Diabetes Association: collaborator
• W.K. Kellogg Foundation: collaborator
• Centers for Disease Control and Prevention: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Toronto: collaborator

Study Sites (1)

Kaiser Permanente Northern California, Division of Research

Oakland, California, 94612, United States

Location

Related Publications (23)

• 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.

  PMID: 24402327 RESULT

• Gunderson EP. The role of lactation in GDM women. Clin Obstet Gynecol. 2013 Dec;56(4):844-52. doi: 10.1097/GRF.0b013e3182a8e067.

  PMID: 24100596 RESULT

• Gunderson 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.

  PMID: 29691992 RESULT

• Batchuluun 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.

  PMID: 29436377 RESULT

• Davis 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.

  PMID: 28794888 RESULT

• Gunderson 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.

  PMID: 27538169 RESULT

• Allalou 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.

  PMID: 27338739 RESULT

• Gunderson 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.

  PMID: 26595611 RESULT

• Gunderson 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.

  PMID: 26177722 RESULT

• Gunderson 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.

  PMID: 24931281 RESULT

• Gunderson 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.

  PMID: 22914402 RESULT

• Gunderson 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.

  PMID: 22011407 RESULT

• Gunderson 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.

  PMID: 22196129 RESULT

• Gunderson 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.

  PMID: 29049465 RESULT

• Khan 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.

  PMID: 30645667 RESULT

• Faith MS, Hittner JB, Hurston SR, Yin J, Greenspan LC, Quesenberry CP Jr, Gunderson EP; SWIFT Offspring Study Investigators. Association of Infant Temperament With Subsequent Obesity in Young Children of Mothers With Gestational Diabetes Mellitus. JAMA Pediatr. 2019 May 1;173(5):424-433. doi: 10.1001/jamapediatrics.2018.5199.

  PMID: 30855657 RESULT

• Lai M, Liu Y, Ronnett GV, Wu A, Cox BJ, Dai FF, Rost HL, Gunderson EP, Wheeler MB. Amino acid and lipid metabolism in post-gestational diabetes and progression to type 2 diabetes: A metabolic profiling study. PLoS Med. 2020 May 20;17(5):e1003112. doi: 10.1371/journal.pmed.1003112. eCollection 2020 May.

  PMID: 32433647 RESULT

• Lai M, Al Rijjal D, Rost HL, Dai FF, Gunderson EP, Wheeler MB. Underlying dyslipidemia postpartum in women with a recent GDM pregnancy who develop type 2 diabetes. Elife. 2020 Aug 4;9:e59153. doi: 10.7554/eLife.59153.

  PMID: 32748787 RESULT

• Vandyousefi S, Davis JN, Gunderson EP. Association of infant diet with subsequent obesity at 2-5 years among children exposed to gestational diabetes: the SWIFT study. Diabetologia. 2021 May;64(5):1121-1132. doi: 10.1007/s00125-020-05379-y. Epub 2021 Jan 26.

  PMID: 33495846 RESULT

• Zhang Z, Lai M, Piro AL, Alexeeff SE, Allalou A, Rost HL, Dai FF, Wheeler MB, Gunderson EP. Intensive lactation among women with recent gestational diabetes significantly alters the early postpartum circulating lipid profile: the SWIFT study. BMC Med. 2021 Oct 8;19(1):241. doi: 10.1186/s12916-021-02095-1.

  PMID: 34620173 RESULT

• Zhang Z, Piro AL, Allalou A, Alexeeff SE, Dai FF, Gunderson EP, Wheeler MB. Prolactin and Maternal Metabolism in Women With a Recent GDM Pregnancy and Links to Future T2D: The SWIFT Study. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2652-2665. doi: 10.1210/clinem/dgac346.

  PMID: 35666146 RESULT

• Khan SR, Manialawy Y, Obersterescu A, Cox BJ, Gunderson EP, Wheeler MB. Diminished Sphingolipid Metabolism, a Hallmark of Future Type 2 Diabetes Pathogenesis, Is Linked to Pancreatic beta Cell Dysfunction. iScience. 2020 Sep 15;23(10):101566. doi: 10.1016/j.isci.2020.101566. eCollection 2020 Oct 23.

  PMID: 33103069 RESULT

• Matias SL, Dewey KG, Quesenberry CP Jr, Gunderson EP. Maternal prepregnancy obesity and insulin treatment during pregnancy are independently associated with delayed lactogenesis in women with recent gestational diabetes mellitus. Am J Clin Nutr. 2014 Jan;99(1):115-21. doi: 10.3945/ajcn.113.073049. Epub 2013 Nov 6.

  PMID: 24196401 RESULT

Related Links

• Breastfeeding Research conducted at the KPNC, Division of Research, Oakland CA
• BMJ Summarizes the Primary Findings from the SWIFT Study 2015
• SWIFT Study Website

Biospecimen

Retention: SAMPLES WITH DNA

We collected fasting and 2-hour post-load plasma specimens during each 2-hour 75 gram Oral Glucose Tolerance Test (OGTT) from three longitudinal research exams at 6 to 9 weeks postpartum (study baseline), and at research exams at 1 year and 2 years post-baseline. The EDTA treated plasma specimens and buffy coats are stored in cryovials at -80 degrees Centrigrade in low temperature freezers at the Division of Research Clinic in Oakland, CA.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes, Gestational; Breast Feeding; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erica P Gunderson, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 22, 2013
• Study Start: May 1, 2008
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

US (1)