DRKS00019897招募中未知
Randomized, Controlled Pilot-Study to Evaluate the Safety and immune regulatory effect of ProLon®, a Fasting-Mimicking Diet (FMD), on Inflammatory Cardiomyopathy (CMP) - FMDiCMP
Medizinische Klinik für Kardiologie am Campus Benjamin Franklin der Charité - Universitätsmedizin Berlin0 个研究点目标入组 40 人开始时间: 2020年3月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Ability and willingness to provide written informed consent;
- •2. Ability and willingness to do the study tests;
- •3. Diagnosed with inflammatory cardiomyopathy based on myocardial biopsy
排除标准
- •1. Systolic blood pressure <90 mmHg and/or diastolic pressure <50 mmHg (measured at screening);
- •2. History of gastric bypass (based on medical history provided at screening);
- •3. Type 1 diabetes (based on medical history provided at screening);
- •4. Taking insulin, insulin analogs, or octreotide (based on medical history provided at screening);
- •5. Receiving medications for diabetes: DDP-4 inhibitors, GLP-1 agonists, Sulfonylureas, Meglitinides, D-Phenylalanine Derivatives, Thiazolidinediones Pioglitazone (TZDs) Alpha-glucosidase Inhibitors, Bile Acid Sequestrants, Combination Pills, Insulin (based on medical history provided at screening).
- •6. Hemoglobin < 9.0 g/dl;
- •7. Immune depressed (CBC at screening);
- •8. White blood cell count < 3,500/mm^3;
- •9. Neutrophil count < 2,000/mm^3;
- •10. Platelet count < 125,000/mm^3;
- •11. Receiving immunosuppressive therapy (i.e., oral prednisone in doses > 10 mg daily) (based on medical history provided at screening);
- •12. Cancer diagnosis;
- •13. Unintentional weight loss >5% in the preceding 6 months
- •14. Uncontrolled severe hypertension (SBP/DBP >180/100)
- •15. Females who are pregnant or nursing
研究者
相似试验
撤回
3 期
A Pilot Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for Superficial Skin Cancer.Basal Cell CarcinomaACTRN12615001061527St Vincent's Hospital, Sydney100
尚未招募
3 期
A Pilot, Randomised Controlled Study of Ivabradine for Heart Rate Reduction in Critically Ill Patients with Septic ShockSeptic shockACTRN12618001675213Perioperative and Critical Care Research Monash Medical Centre20
已完成
2 期
Effect of meditation on quality of life in hematopoietic cell transplant patientsCTRI/2021/09/036667Postgraduate Institute of Medical Education Research PGIMER72
已完成
不适用
A pilot trial to evaluate the effectiveness and safety of scalp acupuncture and electro-magnetic convergence stimulation in patient with cerebral infarctioDiseases of the nervous systemKCT0001768Dongshin University60
尚未招募
Unknown
A randomized controlled pilot trial to evaluate the effectiveness and safety of a memory-supporting digital intervention for adult patients with Mild Cognitive Impairment (MCI) and Mild Alzheimer's Dementia (AD)Dementia in Alzheimer diseaseF06.7Mild cognitive disorderDRKS00034475Cogthera GmbH140