Status:
COMPLETED
The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18+ years
Brief Summary
The primary aim of the study is to evaluate postprandial gallbladder emptying and plasma concentrations of the glucose-lowering and satiety-promoting gut hormone glucagon-like peptide 1 (GLP-1) during...
Detailed Description
Gestational diabetes mellitus (GDM) defined as glucose intolerance first detected during pregnancy is a strong predictor of future type 2 diabetes. Patients with GDM exhibit severely reduced postprand...
Eligibility Criteria
Inclusion
- Inclusion criteria - women with gestational diabetes mellitus (GDM):
- GDM diagnosed according to current Danish guidelines (plasma glucose (PG) concentration at 120 min after a 75 g oral glucose tolerance test (OGTT) ≥9.0 mM)
- Caucasian ethnicity
- Age \>18 years
- Pre-pregnancy BMI \<30 kg/m2 and third trimester BMI \<35 kg/m2
- Informed oral and written consent
- Exclusion criteria - women with gestational diabetes:
- Anaemia (haemoglobin \<7.5 mM)
- Previous preeclampsia, HELLP syndrome (haemolysis, elevated liver enzymes and low platelets) and/or pregnancy-induced intrahepatic cholestasis
- Gastrointestinal disease, previous gastric or intestinal resection, cholecystectomy and/or any major intra-abdominal surgery
- Previous pancreatic disease and/or neoplasia
- Postpartum use of hormonal contraception including intrauterine device
- Any condition the investigator group suspect would interfere with trial participation
- Inclusion criteria - control group:
- Normal glucose tolerance (fasting plasma glucose (PG) concentration ≤6.0 mM and PG concentration at 120 min after a 75 g-OGTT \<7.8 mM)
- Caucasian ethnicity
- Age \>18 years
- Pre-pregnancy BMI \<30 kg/m2 and third trimester BMI \<35 kg/m2
- Informed oral and written consent
- Exclusion criteria - control group:
- Anaemia (haemoglobin \<7.5 mM)
- Previous preeclampsia, HELLP syndrome (haemolysis, elevated liver enzymes and low platelets) and/or pregnancy induced intrahepatic cholestasis
- Gastrointestinal disease, previous gastric or intestinal resection, cholecystectomy and/or any major intra-abdominal surgery
- Previous pancreatic disease and/or neoplasia
- Postpartum use of hormonal contraception including intrauterine device
- Verified prior GDM
Exclusion
Key Trial Info
Start Date :
October 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04108065
Start Date
October 2 2019
End Date
October 30 2020
Last Update
December 21 2020
Active Locations (1)
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1
Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen
Hellerup, Denmark, 2900