Gestational Diabetes Mellitus
Conditions
Brief summary
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
Interventions
DRUGExendin 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
Sponsors
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| G50 | During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery. | The change in glucose concentration necessary to suppress glucagon secretion rate by 50%. A measurement of α-cell function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucagon Secretion Rate | During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery. | The amount of glucagon produced over time expressed as pmol/min. A measurement of α-cell function. |
| delta insulin secretion rate/delta glucose | During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery. | This measurement quantifies the change in insulin secretion in response to rising glucose concentrations. it is a surrogate of β-cell function. Insulin secretion rate will be calculated from C-peptide concentrations using nonparametric deconvolution and population-based measures of C-peptide kinetics. |
| β-Cell responsivity (Φ) | During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery. | This index quantifies the relationship between fasting glucose and fasting insulin secretion rate. This will allow us to assess and quantify fasting β-cell function. |
Countries
United States
Contacts
CONTACTJeanette Laugen
CONTACTAmy Zipse
PRINCIPAL_INVESTIGATORAoife Egan, MB, BCh, PhD
Mayo Clinic
Outcome results
None listed