A Study to Evaluate Proinsulin and Glucagon Secretion in Postpartum Women with and without Gestational Diabetes
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-011294
Sponsor Protocol Number: 18-011294
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Adrian Vella, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available