377. Combined Treatment of Intrapancreatic Autologous Bone Marrow Stem Cells and Hyperbaric Oxygen in Type 2 Diabetes Mellitus Randomized Clinical Trials
| Autor: | Aldo Rodríguez Saavedra, Esteban J. Estrada, Eduardo A. Nicora, María Julia Esperanza, Jose L. Decima, Elida Beatriz Romero, Gustavo Samaja |
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| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Type 2 diabetes Gastroenterology law.invention chemistry.chemical_compound Randomized controlled trial law Internal medicine Drug Discovery Genetics medicine Clinical endpoint Molecular Biology Pharmacology business.industry C-peptide Insulin Type 2 Diabetes Mellitus Stem-cell therapy medicine.disease Metformin Endocrinology chemistry Molecular Medicine business medicine.drug |
| Zdroj: | Molecular Therapy. 23:S150 |
| ISSN: | 1525-0016 |
| DOI: | 10.1016/s1525-0016(16)33986-7 |
| Popis: | T2DM is a pandemic disease with a serious health complications, however stem cells therapy appear to be a new therapeutic option.This prospective, open labeled, randomized controlled clinical trial a phase I/II study, comparing the benefit of hyperbaric oxygen therapy and intra-pancreatic stem cell infusion vs. control group with standard medical treatment (insulin + metformin) for type 2 diabetes mellitus.The objective of this study was to determine whether intra-pancreatic infusion of bone marrow derived autologous stem cells in combination with hyperbaric oxygen therapy could improve metabolism in patients with type 2 diabetes mellitus. The primary endpoint was HbA1c reduction.The Patients with T2DM enrolled were 23. They were randomized and assigned, to intervention group 13 patients and 10 to control group. They were followed for 1 year.Metabolic variables included (fasting plasma glucose, C-peptide, HbA1c, and calculation of C peptide/glucose ratio) and clinical variables (BMI, insulin requirement) were measured at baseline and at 180, 270 and 365 days.At baseline there was no significance difference between groups in HbA1C, glucose, c-peptide, c peptide/glucose and insulin, BMI was greater in the intervention group than in the control group (diff=3.93, p=0.006). At 365 days in the intervention group HbA1C changes were significant (diff=-0.76, p=0.05), glucose (diff=-64.1, diff 0.001), c-peptide (diff=1.25, p< 0.001), c peptide/glucose (diff=0.01, p< 0.0001). Changes in A1c compared (both groups) to time 0 were not significant to the control group at any time during follow up, but were significantly decreased in the intervention group at 365 days (diff=-1.08, p |
| Databáze: | OpenAIRE |
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