NCT04108065

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

September 25, 2019

Last Update Submit

December 18, 2020

Conditions

Gestational Diabetes Mellitus

Keywords

gestational diabetes mellitusgallbladder motilityglp-1pregnancy

Outcome Measures

Primary Outcomes (2)

  • GLP-1 response

    Postprandial GLP-1 response (as assessed by area under curve (AUC) within 240 minutes after meal ingestion) during third trimester compared to 3-9 months postpartum.

    240 minutes

  • Gallbladder emptying

    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 3-9 months postpartum.

    240 minutes

Secondary Outcomes (5)

  • Responses of glucose, insulin, C-peptide, glucagon, GIP

    240 minutes

  • Gastric emptying

    240 minutes

  • Bile acid and gallbladder physiology

    240 minutes

  • Oxytocin

    240 minutes

  • GDF15

    240 minutes

Study Arms (2)

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)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

October 2, 2019

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)