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Purpose

The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.

Condition

Eligibility

Eligible Ages
Between 20 Years and 40 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pregnant individuals with a viable singleton pregnancy who have completed second trimester gestational diabetes screening and are eligible for classification as either gestational diabetes mellitus or no gestational diabetes mellitus. - Participants must be willing and able to provide informed consent and complete planned pregnancy and postpartum study visits.

Exclusion Criteria

  • Active systemic illness (e.g. chronic kidney disease, hypertension) - Pre-pregnancy diabetes mellitus - Multiple gestation, major fetal anomaly, or non-viable pregnancy on ultrasound - Fasting glucose ≥ 100 mg/dL or HbA1c ≥ 5.7% in early pregnancy - One abnormal value on the 3-hour 100 g oral glucose tolerance test - Glucose at least 190 mg/dL on glucose challenge testing without subsequent 3-hour oral glucose tolerance testing - Use of medication affecting glucose metabolism before pregnancy or in early pregnancy - Use of glucose-lowering medication (e.g. metformin, glyburide) other than insulin to treat gestational diabetes mellitus in the current pregnancy - History of upper gastrointestinal surgery that alters gastric emptying (e.g. bariatric surgery) - Hemoglobin < than 11 g/dL

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Women With Gestational Diabetes Mellitus 		Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits.
  • Drug: Exendin 9-39
    Exendin 9-39 will be administered during one postpartum study day as an intravenous infusion at 300 pmol/kg/min for 4 hours, beginning 60 minutes before the graded glucose infusion and continuing through the end of the 180-minute glucose infusion study period
Experimental
Women Without Gestational Diabetes Mellitus 		Pregnant participants without gestational diabetes mellitus, matched to the gestational diabetes group by parity, age, ethnicity, gestational week at diagnosis comparator timepoint, and first trimester body mass index.
  • Drug: Exendin 9-39
    Exendin 9-39 will be administered during one postpartum study day as an intravenous infusion at 300 pmol/kg/min for 4 hours, beginning 60 minutes before the graded glucose infusion and continuing through the end of the 180-minute glucose infusion study period

Recruiting Locations

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Jeanette Laugen
507-255-8110

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Jeanette Laugen
507-255-8110
laugen.jeanette@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.