Islet Function in Gestational Diabetes
4. september 2026 opdateret af: Aoife Egan, Mayo Clinic
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
90
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jeanette Laugen
- Telefonnummer: 507-255-8110
- E-mail: laugen.jeanette@mayo.edu
Undersøgelse Kontakt Backup
- Navn: Amy Zipse
- Telefonnummer: 507-255-9278
- E-mail: zipse.amy@mayo.edu
Studiesteder
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic
-
Kontakt:
- Jeanette Laugen
- Telefonnummer: 507-255-8110
-
Kontakt:
- Amy Zipse
- Telefonnummer: 507-255-9278
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Women With Gestational Diabetes Mellitus
Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits.
|
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
|
|
Eksperimentel: 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.
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
G50
Tidsramme: 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.
|
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Glucagon Secretion Rate
Tidsramme: 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.
|
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
|
|
delta insulin secretion rate/delta glucose
Tidsramme: 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.
|
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
|
|
β-Cell responsivity (Φ)
Tidsramme: 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.
|
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Aoife Egan, MB, BCh, PhD, Mayo Clinic
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. marts 2030
Studieafslutning (Anslået)
1. december 2030
Datoer for studieregistrering
Først indsendt
1. september 2026
Først indsendt, der opfyldte QC-kriterier
4. september 2026
Først opslået (Faktiske)
8. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-007703
- 1R01DK148528-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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