Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia

Gestational Diabetes Clinical Trial

Official title:

Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04521712
• Other study ID #: 300005510
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: Ashley N Battarbee, MD, MSCR
• Phone: 205-975-2361
• Email: anbattarbee[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria for early GDM women:

• Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
• Gestational diabetes mellitus identified at < 20 weeks' gestation requiring pharmacologic treatment (class A2)

Exclusion Criteria for early GDM women:

• History of prediabetes or polycystic ovarian syndrome
• History of pregestational type 2 diabetes mellitus
• Skin conditions which prevent wearing a continuous glucose monitor

Inclusion Criteria for 3rd trimester GDM women:

• Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
• Gestational diabetes mellitus identified at >= 24 weeks' gestation requiring pharmacologic treatment (class A2)

Exclusion Criteria for 3rd trimester GDM women:

• History of prediabetes or polycystic ovarian syndrome
• History of pregestational type 2 diabetes mellitus
• Skin conditions which prevent wearing a continuous glucose monitor

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Hyperglycemia

Intervention

Diagnostic Test:
• 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
All women enrolled in this study will have a 2-hour 75-g oral glucose tolerance test performed immediately postpartum (within 4 days of delivery), at 4-6 weeks postpartum, and at 6 months postpartum. Enrolled women will also wear a continuous glucose monitor for 10 days at each of these time periods. Both women and their infants will have skin fold thickness measured at each of these 3 study visits to estimate body fat composition. Additionally umbilical cord blood and placental biopsies will be collected at delivery and stored for future research.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (20)

ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. — View Citation

Battarbee AN, Yee LM. Barriers to Postpartum Follow-Up and Glucose Tolerance Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2018 Mar;35(4):354-360. doi: 10.1055/s-0037-1607284. Epub 2017 Oct 11. — View Citation

Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8. — View Citation

Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5. — View Citation

Benhalima K, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Minschart C, Devlieger R, Mathieu C. Characteristics and pregnancy outcomes across gestational diabetes mellitus subtypes based on insulin resistance. Diabetologia. 2019 Nov;62(11):2118-2128. doi: 10.1007/s00125-019-4961-7. Epub 2019 Jul 23. — View Citation

Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003 Oct;14(4):256-60. doi: 10.1080/jmf.14.4.256.260. — View Citation

Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600. — View Citation

Immanuel J, Simmons D. Screening and Treatment for Early-Onset Gestational Diabetes Mellitus: a Systematic Review and Meta-analysis. Curr Diab Rep. 2017 Oct 2;17(11):115. doi: 10.1007/s11892-017-0943-7. — View Citation

Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462. — View Citation

Metzger BE, Cho NH, Roston SM, Radvany R. Prepregnancy weight and antepartum insulin secretion predict glucose tolerance five years after gestational diabetes mellitus. Diabetes Care. 1993 Dec;16(12):1598-605. doi: 10.2337/diacare.16.12.1598. — View Citation

Moy FM, Ray A, Buckley BS, West HM. Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD009613. doi: 10.1002/14651858.CD009613.pub3. — View Citation

O'Sullivan JB. Gestational diabetes and its significance. Adv Metab Disord. 1970;1:Suppl 1:339+. doi: 10.1016/b978-0-12-027361-4.50040-5. No abstract available. — View Citation

O'SULLIVAN JB. Gestational diabetes. Unsuspected, asymptomatic diabetes in pregnancy. N Engl J Med. 1961 May 25;264:1082-5. doi: 10.1056/NEJM196105252642104. No abstract available. — View Citation

Pontiroli AE, Pizzocri P, Caumo A, Perseghin G, Luzi L. Evaluation of insulin release and insulin sensitivity through oral glucose tolerance test: differences between NGT, IFG, IGT, and type 2 diabetes mellitus. A cross-sectional and follow-up study. Acta Diabetol. 2004 Jun;41(2):70-6. doi: 10.1007/s00592-004-0147-x. — View Citation

Powe CE, Allard C, Battista MC, Doyon M, Bouchard L, Ecker JL, Perron P, Florez JC, Thadhani R, Hivert MF. Heterogeneous Contribution of Insulin Sensitivity and Secretion Defects to Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1052-5. doi: 10.2337/dc15-2672. Epub 2016 May 13. — View Citation

Raman P, Shepherd E, Dowswell T, Middleton P, Crowther CA. Different methods and settings for glucose monitoring for gestational diabetes during pregnancy. Cochrane Database Syst Rev. 2017 Oct 29;10(10):CD011069. doi: 10.1002/14651858.CD011069.pub2. — View Citation

Stumvoll M, Fritsche A, Haring H. The OGTT as test for beta cell function? Eur J Clin Invest. 2001 May;31(5):380-1. doi: 10.1046/j.1365-2362.2001.00828.x. No abstract available. — View Citation

Stumvoll M, Van Haeften T, Fritsche A, Gerich J. Oral glucose tolerance test indexes for insulin sensitivity and secretion based on various availabilities of sampling times. Diabetes Care. 2001 Apr;24(4):796-7. doi: 10.2337/diacare.24.4.796. No abstract available. — View Citation

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. — View Citation

Yogev Y, Ben-Haroush A, Chen R, Kaplan B, Phillip M, Hod M. Continuous glucose monitoring for treatment adjustment in diabetic pregnancies--a pilot study. Diabet Med. 2003 Jul;20(7):558-62. doi: 10.1046/j.1464-5491.2003.00959.x. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic beta cell function	Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.	4-6 weeks after delivery
Secondary	Maternal glycemia measured by CGM	% time in range	10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Secondary	Maternal hyperglycemia measured by CGM	% time above range	10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Secondary	Maternal glucose variability	Coefficient of variation (glucose standard deviation/mean glucose)	10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Secondary	Pancreatic beta cell function	Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.	0-4 days and 6 months after delivery
Secondary	Maternal and infant body fat composition	Percentage body fat calculated from skin fold thickness measurements of upper mid-arm, triceps, subscapular, and flank along with height and weight for the mother and length, birthweight and head circumference for the infant.	0-4 days, 4-6 weeks, and 6 months after delivery
Secondary	Maternal diabetes mellitus	Fasting blood glucose >= 126mg/dL or 2-hour blood glucose >=200 mg/dL after 75g oral glucose load.	4-6 weeks and 6 months after delivery