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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
Sponsor:
Information provided by (Responsible Party):
Filip Krag Knop, University Hospital, Gentofte, Copenhagen

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 third trimester of pregnancy in women with gestational diabetes mellitus (GDM) compared with age and body mass index (BMI)-matched pregnant control women with normal glucose tolerance (NGT).

Condition or disease
Gestational Diabetes Mellitus

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 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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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. Only pregnant women who have been tested for gestational diabetes mellitus will be enrolled in the study.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Filip K Knop, Professor, MD, Ph.d. +45 38674266 filip.krag.knop.01@regionh.dk
Contact: Ida Marie Gether, BSc +45 24246625 ida.marie.gether.01@regionh.dk

Locations
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Denmark
Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen Recruiting
Hellerup, Denmark, 2900
Contact: Filip K Knop, Professor, MD, Ph.D.    +45 38674266    filip.krag.knop.01@regionh.dk   
Contact: Ida Marie Gether, BSc    +45 24246625    ida.marie.gether.01@regionh.dk   
Principal Investigator: Filip K Knop, Professor, MD, Ph.D.         
Sub-Investigator: Ida Marie Gether, BSc         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen

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Responsible Party: Filip Krag Knop, Professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT04108065     History of Changes
Other Study ID Numbers: H-19036095
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Filip Krag Knop, University Hospital, Gentofte, Copenhagen:
gestational diabetes mellitus
gallbladder motility
glp-1
pregnancy
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications