DRKS00019897
Recruiting
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 sites40 target enrollmentMarch 17, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Inflammatory Cardiomyopathy
- Sponsor
- Medizinische Klinik für Kardiologie am Campus Benjamin Franklin der Charité - Universitätsmedizin Berlin
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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