SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A randomised double-blind placebo-controlled trial (SEESAW)

niversity of Leicester0 个研究点目标入组 68 人开始时间: 2016年7月20日最近更新: 2022年11月7日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35441435/ (added 26/10/2022)

•1. Male and postmenopausal female participants aged between 30-70 years of age inclusive
•2. Type 2 diabetes on diet and lifestyle control or stable dose of metformin only for at least 3 months
•3. Stable weight (less than 5% change in body weight in last 3 months) – determined by self-reporting or documentation in clinical records
•4. HbA1c 48-86mmol/mol (6.5 - 10%)
•5. eGFR=60ml/min/1.73m2
•6. BMI = 25kg/m2
•7. Able and willing to give informed consent
•8. Able to understand English

•1. Females who are not postmenopausal (as menstrual cycle can affect appetite hormone concentrations) which is defined as 2 years post last menstrual period <50 years of age or 1 year post last menstrual period >50 years of age.”
•2. Type 2 diabetes on any other glucose lowering treatment except metformin
•3. Patients with Type 1 diabetes
•4. Patients on loop diuretics
•5. Age <30 years and >70 years
•6. BMI <25kg/m2
•7. Not able to give informed consent
•8. Not able to understand English
•9. Moderate to severe renal impairment (eGFR<60ml/min/1.73m2)
•10. Unstable diabetes i.e. HbA1c >86mmol/mol (10%), recent hospital admission with diabetic emergency in last 3 months
•11. Patients with familial renal glycosuria
•12. Patients with recurrent balanitis, vaginal or urinary tract infections
•13. Shift workers
•14. Patients who have participated in another study of an investigational medicinal product in the last 3 months
•15. Active malignancy
•16. Serious illness with a life-expectancy of less than 1 year
•17. Hypersensitivity to Empagliflozin (Jardiance™) or to any of the excipients
•18. Patients with latent autoimmune diabetes in adults (LADA)
•19. Patients with a history of chronic pancreatitis
•20. Evidence of conditions that lead to restricted food intake or severe dehydration
•21. Patients with a history of excessive alcohol consumption
•22. Patients on a severely calorie restricted diet (i.e., =800 calories per day)

发起方

niversity of Leicester