The impact of liraglutide on glucose tolerance and the risk of type 2 diabetes in women with previous gestational diabetes mellitus

Phase 1

• Conditions: Gestational diabetes mellitus Non-alcoholic fatty liver disease; MedDRA version: 20.0 Level: LLT Classification code 10018210 Term: Gestational diabetes mellitus System Organ Class: 100000004868; MedDRA version: 20.1 Level: PT Classification code 10029530 Term: Non-alcoholic fatty liver System Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001371-37-DK
• Lead Sponsor: Dr. med. Tina Vilsbøll

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

Women with previous GDM:
• Informed oral and written consent
• Previous diagnosis of GDM according to current Danish guidelines (plasma glucose concentration at 120 min after 75 g oral glucose tolerance test =9.0 mM) during pregnancy within the last 10 years
• Age >18 years
• 25 kg/m2 < body mass index < 45 kg/m2
• Normal glucose tolerance (NGT), impaired fasting glycaemia (IFG), or impaired glucose tolerance (IGT)
• Safe contraception and negative pregnancy test

Women without previous GDM
•Informed oral and written consent
•Normal glucose tolerance (fasting PG = 6.0 mM and PG concentration at 120 min after 75 g-OGTT < 7.8 mM)
•Age >18 years
•25 kg/m2 < BMI < 45 kg/m2
•Pregnancy within the last ten years without GDM

Women without previous GDM and without NAFLD
•Informed oral and written consent
•Normal glucose tolerance (fasting PG < 6.1 mM and HbA1c < 43 mmol/mol)
•Age >18 years
•25 kg/m2 < BMI < 45 kg/m2
•At least one pregnancy within the last ten years without GDM

Women with biopsi-verified NAFLD
•Informed oral and written consent
•Women with known NAFLD or NASH
•25 kg/m2 < BMI < 45 kg/m2
•Age >18 years
•At least one prior pregnancy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women with previous GDM
• Patients with diabetes
• HbA1c =6.5%
• Patients with previous pancreatitis or previous neoplasia
• Pregnant or breast feeding women
• Anaemia (haemoglobin <7 mM)
• Women planning to become pregnant within the next 5 years
• Women using other contraception than intrauterine device (IUD) or oral contraceptives. Women who do not use safe contraception will be offered application of an IUD.
• Women treated with statins, corticosteroids or other hormone therapy (except estrogens and gestagens)
• Ongoing abuse of alcohol or narcotics
• Impaired hepatic function (liver transaminases >3 times upper normal limit)
• Impaired renal function (se-creatinine >120 µM and/or albuminuria)
• Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
• Any condition that the investigator feels would interfere with trial participation
• Receiving any investigational drug within the last 3 months

Women without previous GDM
•Pregnant or breast feeding women
•Anaemia (haemoglobin <7 mM)

Women without previous GDM and without NAFLD
•Pregnant or breast feeding women
•Anaemia (haemoglobin <7 mM)
•Steatosis as assessed by ultrasound scanning
•Receiving any investigational drug within the last 3 months
•Any condition that the investigator feels would interfere with trial participation

Women with biopsi-verified NAFLD
•Women with established cirrhosis
•Pregnant or breast feeding women
•Anaemia (haemoglobin <7 mM)
•Women treated with statins, corticosteroids or other hormone therapy (except oestrogens and gestagens)
•Ongoing abuse of alcohol or narcotics
•Impaired renal function (se-creatinine >120 µM and/or albuminuria)
•Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
•Any condition that the investigator feels would interfere with trial participation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified