The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tina Vilsboll
• Collaborators: Aarhus University Hospital; Herlev Hospital; Hillerod Hospital, Denmark; Hvidovre University Hospital; Novo Nordisk A/S; Rigshospitalet, Denmark; The Novo Nordisk Foundation Center for Basic Metabolic Research; University of Copenhagen
• Treatments: Liraglutide

Criteria

Inclusion Criteria for women with previous GDM:

• Informed oral and written consent

• Previous diagnosis of GDM according to current Danish guidelines (mainly PG concentrationa t 120 min after 75 g OGTT ≥ 9.0 mM) during pregnancy within the last 5 years

• Age >18 years

• 25 kg/m2 < BMI < 45 kg/m2

• NGT, IFG and or IGT

• Safe contraception and negative pregnancy test

Exclusion Criteria for 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

Inclusion criteria for women without previous GDM:

• Informed oral and written consent

• Age >18 years

• 25 kg/m2 < BMI < 45 kg/m2

• NGT

• Safe contraception and negative pregnancy test

• Pregnancy within the last ten years without GDM

Exclusion Criteria for women without previous GDM :

• Pregnant or breast feeding women

• Anaemia (haemoglobin <7 mM)

Inclusion Criteria for women without previous GDM and without NAFLD:

• Informed oral and written consent

• Age >18 years

• 25 kg/m2 < BMI < 45 kg/m2

• NGT

• At least one pregnancy witin the last ten years without GDM

Exclusion Criteria for women without previous GDM and without NAFLD:

• Pregnant or breast feeding women

• Anaemia (haemoglobin <7 mM)

• Steatosis as assessed by ultrasound scanning

• Recieving any investigational drug within the last 3 months

• Any condition that the investigator feels would interfere with the trial participation

Inclusion Criteria for women with biopsi-verified NAFLD:

• Informed oral and written consent

• Women with known NAFLD or NASH

• Age >18 years

• 25 kg/m2 < BMI < 45 kg/m2

• NGT

• At least one prior pregnancy

Exclusion Criteria for women with biopsi-verified NAFLD:

• women with established cirrhosis

• Pregnant or breast feedning 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 presure > 100 mmHg)

• Any condition that the investigator feels would interfere with trial participation