Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of type 2 diabetes
研究概览
简要总结
Obese women with history of gestational diabetes are in great danger to develop type 2 diabetes (T2D) within 5-10 years after delivery. Aim of the study is to investigate if 12 months' liraglutide treatment could decrease the risk of T2D in obese women who have had gestational diabetes. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group, once daily. Same laboratory tests are taken and instructions given at baseline 6 month and one year. After one year visits once a year until 5 years with same laboratory tests and measurements are taken.
详细描述
Incidence of type 2 diabetes (T2D) is increasing along with pandemia of obesity. Gestational diabetes is the major risk factor for T2D in women and more than every tenth will develop gestational diabetes during pregnancy. T2D can be prevented by weight loss. Health care professionals should take advantage of this opportunity to prevent this devastating disease in women.
Aim of the study is to investigate if 12 months' liraglutide treatment (1.8 mg) once daily could decrease the risk of T2D in obese women who have had gestational diabetes needing treatment with metformin and/or insulin.
100 women, who have had gestational diabetes with treatment with metformin and/or insulin and who have stopped lactation and are not pregnant are enrolled between 6 to 18 months after delivery. BMI should be ≥30 kg/m2. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group. Both treatments are given by similar device s.c. once daily during 365 days. Before starting the treatment, clinical examination and laboratory test are done. Similar dietary instructions are given. Same laboratory tests are taken and instructions given at 6 months and at one year after baseline. Additional follow-up call (AE reporting) is scheduled at 3 months and a drug dispensing visit at 9 months. After one year visits once a year until 5 years with same laboratory tests and measurements are taken. Primary end-point is development of T2D (fasting P-glucose >7 mmol/l and/ or 2 h >11 mmol/l in oral glucose tolerance test 75g, and/or HbA1c≥ 6.5 %) from year 1 to 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
double blind
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •history of gestational diabetes with treatment with metformin and/or insulin
- •delivery 6 to 18 months before screening
- •BMI ≥30 kg/m2
- •use of contraceptives (IU-device or oral contraceptive)
排除标准
- •lactation
- •pregnancy
- •type 1 or type 2 diabetes
- •use of antidepressives, statins or anti-hyperglycemic therapies
- •severe hepatic insufficiency
- •end stage renal disease
- •history of pancreatitis
研究组 & 干预措施
liraglutide
干预措施: Liraglutide 6 MG/ML [Victoza] (Drug)
placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Incidence of type 2 diabetes
时间窗: from year 1 to 5
assessed by fasting P-glucose \>7 mmol/l and/ or 2 h \>11 mmol/l in oral glucose tolerance test (OGTT) 75g, and/or HbA1c≥ 6.5 %
次要结局
未报告次要终点
研究者
Heidi Immonen
Principal Investigator, Consultant in Endocrinology
Turku University Hospital
