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Clinical Trial Details

Trial ID: L4782
Source ID: NCT04027023
Associated Drug: Diabetes Mellitus Type 2 De-Escalation Treatment (Det)
Title: Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Diabetes mellitus Type 2 De-escalation treatment (DET)
Outcome Measures: Primary: impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes, combined drug application, 12 weeks | Secondary: HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control, venous blood draw to evaluate the HbA1c, 12 weeks|RBP4 will be measured to evaluate the impact of the poly-pharmaceutical treatment on the RBP4 level, blood draw to measure the above mentioned biomarker, 12 weeks|the biomarker adiponectin will be measured to evaluate the impact of the poly-pharmaceutical treatment on the adiponectin level, blood draw to measure the above mentioned biomarker, 12 weeks|insulin, c-peptide, intact proinsulin, glucagon will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on beta-cell function, blood draw to measure the above mentioned biomarkers, 12 weeks|hsCRP, IL-6, angiopoetin 2 will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on biomarkers of inflammation, blood draw to measure the above mentioned biomarkers, 12 weeks|Questionnaire about the diabetes treatment satisfaction (DTSQ) will be filled by the patient to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on the quality of Life, Questionnaire to be filled by study participant, the scale of the questionnaire reaches from 1 (very good) to 10 (very bad), all questions are bloning to the diabetes treatment., 12 weeks|Renal function, blood draw and urine sample to measure renal function, which will be evaluated with the following parameters creatinine, GFR, total protein (serum and urine), Uric acid and urea before and after the temporary personalized poly-pharmaceutical treatment, 12 weeks|Liver function, blood draw to measure Liver function, which will be evaluated with the following parameters AST, ALT, gamma-GT, and alkaline phosphatase before and after the temporary personalized poly-pharmaceutical treatment, 12 weeks|Heart function, blood draw to measure Heart function, which will be evaluated with the following parameters creatine kinase, and cK-MB before and after the temporary personalized poly-pharmaceutical treatment, 12 weeks|Electrolytic balance, blood draw to measure Electrolytic balance, which will be evaluated with the following parameters: sodium, potassium and calcium before and after the temporary personalized poly-pharmaceutical treatment, 12 weeks
Sponsor/Collaborators: Sponsor: Sciema UG | Collaborators: Innovative Diabetes Treatment Studies LLC.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 9
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-10-30
Completion Date: 2021-05-31
Results First Posted:
Last Update Posted: 2021-04-01
Locations: NYC Research, Inc., New York, New York, 10001, United States|Pfützner Science & Health Institute GmbH, Mainz, Rhineland-Palatinate, 55128, Germany
URL: https://clinicaltrials.gov/show/NCT04027023