Short and long term effect of a Very Low Calorie Diet (VLCD) with or without exercise in obese insulin-dependent type 2 diabetes mellitus patients: A randomised controlled trial

eiden University Medical Center (Netherlands)0 个研究点目标入组 28 人开始时间: 2011年4月5日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Type 2 diabetes mellitus patients
•2. Body mass index (BMI) > 30 kg/m2 (but weight has to be greater than 90 kg to sustain a 16 week VLCD)
•3. Age > 30 years
•4. Use of at least 30 units of insulin/day with or without oral blood glucose lowering agents
•5. Fasting c-peptide level > 0.8 ng/l and a two times rise on 1 mg glucagon (intravenous) IV

•1. No residual insulin secretory capacity as defined by no response to a glucagon stimulation test
•2. Weight above 130 kg and fasting plasma glucose >15 mmol/l
•3. Any significant chronic disease
•4. Renal, hepatic or another endocrine disease
•5. Use of medication known to influence lipolysis and/or glucose metabolism
•6. Recent weight changes or attempts to lose weight ( > 3 kg weight gain or loss, within the last 3 months)
•7. Difficulties to insert an intravenous catheter
•8. Smoking
•9. Severe claustrophobia (ventilated hood)
•10. Recent blood donation (within the last 3 months)
•11. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
•12. Pregnancy
•13. Disease interfering with the use of a thiazolidinediones (TZD) (heart failure, oedema, liver function abnormalities) or participating in regular exercise

发起方

eiden University Medical Center (Netherlands)