EUCTR2012-001371-37-DK进行中（未招募）1 期
The impact of liraglutide on glucose tolerance and the risk of type 2 diabetes in women with previous gestational diabetes mellitus
Dr. med. Tina Vilsbøll0 个研究点目标入组 160 人开始时间: 2012年7月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
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