NL-OMON48777已完成4 期
Combined effects of SGLT2 inhibition and GLP-1 receptor agonism on food intake, body weight and central satiety and reward circuits in obese T2DM patients - DECREASE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •For all 4 study groups:
- •- Age 18-75 years
- •- BMI 25*40 kg/m2
- •- Stable bodyweight (<5% reported change during the previous 3 months).
- •- Diagnosed with T2DM > 3 months prior to screening
- •- Treatment with metformin and/or sulphonylurea at a stable dose for at least 3 months.
- •- HbA1C 7.0*10% for patients treated with metformin
- •- HbA1C 7.5*10% for patients treated with metformin and/or sulphonylurea
- •- Both genders; for women: post menopausal (excluding possible menstruation cycle effects)
排除标准
- •For all 4 study groups:
- •- GLP-1 based therapies, dipeptidyl peptidase (DPP)-4, thiazolidinediones or insulin within 3 months before screening
- •- Weight-lowering agents within 3 months before screening.
- •- Congestive heart failure (NYHA II-IV)
- •- Estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73m2 (per Modification of Diet in Renal Disease (MDRD))
- •- Liver disease
- •- History of gastrointestinal disorders (including gastroparese, pancreatitis and cholelithiasis)
- •- Patients with MEN2 syndrome or history or family history of medullary thyroid carcinoma
- •- Neurological illness
- •- Malignancy (except for basal cell carcinoma)
- •- History of major heart disease
- •- History of major renal disease
- •- Pregnancy or breast feeding
- •- Implantable devices
- •- Substance abuse
- •- Addiction
- •- Alcohol abuse (defined as: for men > 21 units/week, for women >14 units/week)
- •- Smoking/ nicotine abuse (defined as: daily smoking / a daily use of nicotine)
- •- Contra-indication for MRI, such as claustrophobia or pacemaker
- •- psychiatric illnesses; mood disorders, eating disorders, anxiety disorders, schizophrenia and other psychotic disorders, dissociative disorders, somatoform disorders, delirium, dementia and other cognitive disorders
- •- Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening.
- •- Use of cytostatic or immune modulatory agents
- •- History of allergy for exenatide or other GLP-1 RA
- •- Participation in other studies
- •- Individuals who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •- Individuals who are investigator site personnel, directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •- Individuals who have previously completed or withdrawn from this study or any other study investigating GLP-1 receptor agonist or dipeptidyl peptidase (DPP)-4 within 6 months
- •- Visual disability, not correctable with glasses or contact lens
- •- Individuals who, in the opinion of the investigator, are unsuitable in any other way to participate in this study
- •- Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
研究者
相似试验
进行中（未招募）
1 期
De effects of the bloodglucose lowering drugs exenatide (GLP-1 receptor agonist) and dapagliflozine ( a SGLT2 inhibitor) on the brain, food intake and bodyweight.Type 2 diabetes mellitusObesityEUCTR2017-000841-28-NLVU University Medical Center
已完成
4 期
DECREASE: Dapagliflozin Plus Exenatide on Central REgulation of Appetite in diabeteS typE 2ObesityType 2 Diabetes MellitusNCT03361098Amsterdam UMC, location VUmc65
尚未招募
4 期
Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2DMetabolic-associated Fatty Liver DiseaseType 2 DiabetesNCT05140694Seoul National University Bundang Hospital135
已完成
不适用
Effects of treatment with SGLT2 inhibitor on the initiation of continuous positive airway pressure therapy in type 2 diabetic patients with obstructive sleep apnea syndromeType 2 diabetesJPRN-UMIN000045226Akishima Clinic16
进行中（未招募）
不适用
Combination of SGLT2 inhibitor and Intensive Exercise in Diabetes.JPRN-jRCTs071180050Yoshihiro Ogawa146