An open-label randomized trial of an intensive lifestyle package supported with Liraglutide treatment in obese, non-pregnant women with previous history of Gestational Diabetes Mellitus

Clinical Research Centre - University College Dublin0 个研究点目标入组 50 人开始时间: 2016年12月22日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•1. Severe obesity BMI= 35 kg/m2 without Type 2 Diabetes Mellitus and with previous gestational diabetes (with or without insulin)
•2. Participants must be able and willing to give written informed consent and to comply with the requirements of this study protocol
•3. Participant must be a female, aged 18 years or above at baseline
•4. Planning a pregnancy within the next one to two years
•5. Negative pregnancy test
•6. Contraception during the study period
•Removed 02/05/2017:
•Post pregnancy Type 2 Diabetes Mellitus with BMI= 30 kg/m2 and HbA1C >42 mmol/mol

•1. Allergy/sensitivity to study medication
•2. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study period
•3. Medical disorder requiring medication other than stable hypertension, hypothyroidism, polycystic ovarian syndrome
•5. Ongoing abuse of alcohol or narcotics
•6. Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
•7. Personal history of non-familial medullary thyroid carcinoma
•8. History of acute or chronic pancreatitis
•9. Obesity induced by drug treatment
•10. Use of approved weight lowering pharmacotherapy
•11. Previous surgical treatment of obesity
•12. History of major depressive disorder or suicide attempt
•13. Uncontrolled hypertension
•14. Subjects unable to provide written informed consent
•Added 30/05/2017:
•15. Type 2 diabetes mellitus

发起方

Clinical Research Centre - University College Dublin