Status:
COMPLETED
The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes
Lead Sponsor:
Tina Vilsboll
Collaborating Sponsors:
Novo Nordisk A/S
Rigshospitalet, Denmark
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01795248
Start Date
July 1 2012
End Date
September 1 2020
Last Update
November 4 2020
Active Locations (1)
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1
Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
Hellerup, Denmark, 2900