Islet Function in Gestational Diabetes
ConditionGestational Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorMayo Clinic
About this trial
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exendin 9-39
DrugExendin 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
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Women With Gestational Diabetes MellitusExperimental treatment 1 intervention
Group B: Women Without Gestational Diabetes MellitusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
G50
The change in glucose concentration necessary to suppress glucagon secretion rate by 50%. A measurement of α-cell function.
Time frame
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.Secondary outcomes
1
Glucagon Secretion Rate
The amount of glucagon produced over time expressed as pmol/min. A measurement of α-cell function.
Time frame
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.2
delta insulin secretion rate/delta glucose
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.
Time frame
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.3
β-Cell responsivity (Φ)
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.
Time frame
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov