A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes
NCT ID: NCT05280496
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2022-06-01
2025-04-18
Brief Summary
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Detailed Description
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Given the increasing public health burden of DM, there is an urgent need to remedy this problem and correct this deficiency in health care delivery that allows so many at-risk women to remain unidentified and untreated.
Compelling preliminary data, confirmed at several other sites, indicates that the postpartum glucose tolerance test to identify individuals with prediabetes can be moved from 4-12 weeks postpartum to 1-4 days postpartum, when women are still hospitalized, with test compliance of 92% and no reduction in sensitivity or specificity for prediabetes.
When individuals with a history of GDM and prediabetes are prescribed metformin, they experience a 50% reduction in DM risk and a 3 kg increase in weight loss over three years compared to placebo. If these same benefits are realized when metformin is initiated soon after delivery, then a simple change in postpartum care so that metformin is routinely prescribed at hospital discharge to women with a history of GDM and prediabetes could improve the health of thousands of women annually by decreasing the number of women who develop DM and fail to achieve postpartum weight loss.
Each year in the United States, approximately 280,000 women are diagnosed with GDM. Without intervention, up to 70% of these women will develop diabetes mellitus (DM) over their lifetime, resulting in devastating health consequences and escalating health care costs. However, implementing a postpartum glucose tolerance test and intervening with metformin for those with prediabetes may be a cost-effective change to postpartum care that would result in a profound decrease in DM incidence.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Metformin
Participants will be given a daily prescription of metformin for 12 months postpartum. At 12 months and again at 15 months (3 months off the drug), HbA1c and weight will be assessed.
Metformin
Metformin is used to lower blood sugar in patients with high blood sugar (diabetes).
Interventions
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Metformin
Metformin is used to lower blood sugar in patients with high blood sugar (diabetes).
Eligibility Criteria
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Inclusion Criteria
2. Gestational diabetes mellitus diagnosed during pregnancy
3. ≥18 years of age
4. Opted for the 2 hour 75 gram OGTT during postpartum hospitalization
5. Willing and able to sign the informed consent
Exclusion Criteria
2. Contraindications to metformin
* Liver disease
* Impaired renal function (Creatinine Clearance\> )
* Congestive heart failure(CHF)
* Taking drugs that could interfere with metformin metabolism
3. Taking metformin outside of pregnancy
4. Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids).
5. Decided against the 2 hour 75 gram OGTT during postpartum hospitalization.
6. Preexisting diabetes mellitus.
18 Years
FEMALE
No
Sponsors
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Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Erika Werner, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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References
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Charlton JM, van Heyningen R. Glucose 6-phosphate dehydrogenase in the mammalian lens. Exp Eye Res. 1971 Mar;11(2):147-60. doi: 10.1016/s0014-4835(71)80018-0. No abstract available.
Carter EB, Tuuli MG, Odibo AO, Macones GA, Cahill AG. Prenatal visit utilization and outcomes in pregnant women with type II and gestational diabetes. J Perinatol. 2017 Feb;37(2):122-126. doi: 10.1038/jp.2016.175. Epub 2016 Oct 13.
Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available.
Asymptomatic hiatus hernia. Lancet. 1969 Apr 26;1(7600):870-1. No abstract available.
Moin T, Li J, Duru OK, Ettner S, Turk N, Keckhafer A, Ho S, Mangione CM. Metformin prescription for insured adults with prediabetes from 2010 to 2012: a retrospective cohort study. Ann Intern Med. 2015 Apr 21;162(8):542-8. doi: 10.7326/M14-1773.
Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE; Diabetes Prevention Program Research Group. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008 Dec;93(12):4774-9. doi: 10.1210/jc.2008-0772. Epub 2008 Sep 30.
Werner EF, Has P, Rouse D, Clark MA. Two-day postpartum compared with 4- to 12-week postpartum glucose tolerance testing for women with gestational diabetes. Am J Obstet Gynecol. 2020 Sep;223(3):439.e1-439.e7. doi: 10.1016/j.ajog.2020.05.036. Epub 2020 May 26.
Werner EF, Has P, Kanno L, Sullivan A, Clark MA. Barriers to Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2019 Jan;36(2):212-218. doi: 10.1055/s-0038-1667290. Epub 2018 Jul 30.
Werner EF, Has P, Tarabulsi G, Lee J, Satin A. Early Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2016 Aug;33(10):966-71. doi: 10.1055/s-0036-1583193. Epub 2016 Apr 27.
Whelan AR, Ayala NK, Werner EF. Postpartum Use of Weight Loss and Metformin for the Prevention of Type 2 Diabetes Mellitus: a Review of the Evidence. Curr Diab Rep. 2021 Sep 8;21(10):37. doi: 10.1007/s11892-021-01410-7.
Bennett WL, Liu SH, Yeh HC, Nicholson WK, Gunderson EP, Lewis CE, Clark JM. Changes in weight and health behaviors after pregnancies complicated by gestational diabetes mellitus: the CARDIA study. Obesity (Silver Spring). 2013 Jun;21(6):1269-75. doi: 10.1002/oby.20133. Epub 2013 May 13.
Other Identifiers
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STUDY00002576
Identifier Type: -
Identifier Source: org_study_id
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