A Study to Evaluate Proinsulin and Glucagon Secretion in Postpartum Women with and without Gestational Diabetes

Overview

About this study

The purpose of this study is to determine the changes in tissue function that occur in the first year postpartum in women with and without gestational diabetes mellitus.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Fifteen women with GDM and 15 women without GDM will be recruited through the Mayo Clinic Obstetric Practice in Rochester, Minnesota in the third trimester of pregnancy.
  • The screening visit will be scheduled from 2-12 weeks postpartum.
  • Gestational diabetes will be diagnosed based on Carpenter and Coustan criteria when at least two of the following four plasma glucose concentrations [measured fasting and 1h, 2h and 3h during 100g oral glucose tolerance testing)(OGTT)] are met or exceeded:
    • fasting 95mg/dL (5.3mmol/L);
    • 1h 180mg/dL (10.0mmol/L);
    • 2h 155mg/dL (8.6mmol/L); and
    • 3h 140mg/dL (7.8mmol/L).
  • Women will be characterized as having normal glucose tolerance if they do not meet or exceed two or more of the aforementioned values on OGTT. These women will have previously failed a 50g glucose challenge [1 hr glucose >= 140mg/dL (7.8mmol/L).
  • We will also characterize women as having normal glucose metabolism if they passed a 50g glucose challenge in pregnancy [1 hr glucose <140mg/dL (7.8mmol/L)] and did not proceed to further glucose testing during the pregnancy.

Exclusion Criteria:

  • Women < 20 years of age or > 40 years of age will not be studied to minimize the potential confounding effects of extremes of age on glucose absorption and metabolism.
  • Known active systemic illness.
  • Women in which the index pregnancy was a multiple pregnancy.
  • Women with an HbA1c of ≥ 5.7% (39mmol/mol) in early pregnancy or a history of diabetes.
  • Prior therapy with an anti-diabetic medication, or a medication that could affect glucose metabolism.
  • History of abdominal surgery (other than appendectomy, cholecystectomy or tubal ligation).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adrian Vella, M.D.

Open for enrollment

Contact information:

Jeanette Laugen

(507)255-8110

Laugen.Jeanette@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available