The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-02

Study Completion Date

2020-10-30

Brief Summary

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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).

Detailed Description

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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 3-9 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.

Conditions

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Gestational Diabetes Mellitus

Keywords

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gestational diabetes mellitus gallbladder motility glp-1 pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Filip Krag Knop

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-19036095

Identifier Type: -

Identifier Source: org_study_id