The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT04108065|
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : October 11, 2019
|Condition or disease|
|Gestational Diabetes Mellitus|
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 postprandial responses of the insulinotropic and satiety-promoting gut hormone glucagon-like peptide 1 (GLP-1), which normalise alongside remission of GDM after delivery. Ingested nutrients and bile acids constitute potent stimulators of GLP-1 secretion. Reduced postprandial GLP-1 responses likely contribute to the pathophysiology of GDM, but the mechanisms are unknown. Based on previous studies studying gallbladder emptying during pregnancy, we hypothesize that reduced postprandial GLP-1 responses in GDM is due to incomplete gallbladder emptying during third trimester. If our hypothesis proves right, reduced gallbladder emptying and ensuing attenuation of postprandial GLP-1 secretion will constitute an obvious and druggable target for the treatment of GDM.
Fifteen women with gestational diabetes mellitus and 15 age and body mass index (BMI)-matched pregnant women with normal glucose tolerance will be enrolled in the study. For each subject, the study encompasses one screening visit and two experimental days; one during third trimester of pregnancy and one 3-4 months post partum. On experimental days, a standardised liquid mixed meal test (added 1.5 g of paracetamol for evaluation of gastric emptying according to paracetamol absorption) with repeated ultrasonographic gallbladder scans and blood samples will be performed.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus|
|Actual Study Start Date :||October 2, 2019|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Patients 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)
Pregnant women with normal glucose tolerance (control group)
Pregnant women with 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)
- GLP-1 response [ Time Frame: 240 minutes ]Postprandial GLP-1 response (as assessed by area under curve (AUC) within 240 minutes after meal ingestion) during third trimester compared to 3-4 months postpartum.
- Gallbladder emptying [ Time Frame: 240 minutes ]Postprandial gallbladder emptying (evaluated as repeated measures of gallbladder volumes using bed-side ultrasonography within 240 minutes after meal ingestion) during third trimester compared to 3-4 months postpartum.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108065
|Contact: Filip K Knop, Professor, MD, Ph.d.||+45 email@example.com|
|Contact: Ida Marie Gether, BSc||+45 firstname.lastname@example.org|
|Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen||Recruiting|
|Hellerup, Denmark, 2900|
|Contact: Filip K Knop, Professor, MD, Ph.D. +45 38674266 email@example.com|
|Contact: Ida Marie Gether, BSc +45 24246625 firstname.lastname@example.org|
|Principal Investigator: Filip K Knop, Professor, MD, Ph.D.|
|Sub-Investigator: Ida Marie Gether, BSc|