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Clinical Trial Details

Trial ID: L1866
Source ID: NCT04030091
Associated Drug: 3 Hours Humulin R 100 Iu/Ml Pit
Title: Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Diabetes Mellitus, Type 1
Interventions: DRUG: 3 hours humulin R 100 IU/mL PIT|DRUG: 2 hours humulin R 100 IU/mL PIT
Outcome Measures: Primary: Endothelial function, Impact of PIT on endothelial function before and one hour after the PIT initiation measured with the Vendys2 device, 1 hour | Secondary: Renal function, It will be assessed whether insulin resistance has improved or worsened over the course of the study. Measured laboratory parameters for renal function (GFR, creatinine, proteinurea), 13 weeks|nerve function, Sensory nerve function (pathtester, tuning fork). It will be assessed whether insulin resistance has improved or worsened over the course of the study., 13 weeks|Retinopathy, Retinopathy will be measured with the RetinaVue device. It will be assessed whether Retinopathy has improved or worsened over the course of the study., 13 weeks|HbA1c, metabolic control, 13 weeks|Insulin resistance, For assessment of insulin resistance glucose, retinol-binding protein 4 (RBP4), angiopoetin2, adiponectin, interleukin 6 (IL-6), hsCRP, glucagon, insulin, c-peptide, and intact Proinsulin will be measured. Finally, it is assessed whether insulin resistance has improved or worsened over the course of the study., 13 weeks|Diabetes treatment satisfaction questionnaire, Eight questions about the patient´s satisfaction with the diabetes treatment. Answer possibilities range form 1 (very good) to 10 (very bad), 13 weeks
Sponsor/Collaborators: Sponsor: Sciema UG | Collaborators: Innovative Diabetes Treatment Studies LLC.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-09-06
Completion Date: 2020-12-31
Results First Posted:
Last Update Posted: 2021-04-01
Locations: NYC Research, Inc., New York, New York, 10455, United States|Pfützner Science & Health Institute GmbH, Mainz, Rhineland-Palatinate, 55128, Germany
URL: https://clinicaltrials.gov/show/NCT04030091