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Clinical Trials/DRKS00019897
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.

Registry
who.int
Start Date
March 17, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Medizinische Klinik für Kardiologie am Campus Benjamin Franklin der Charité - Universitätsmedizin Berlin

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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