OBJECTIVE: To observe the effect of liraglutide (LIRA) in combination of umbilical cord mesenchymal stem cells (hUC-MSCs) in treating type 2 diabetes mellitus. METHODS: Eligibility criteria for subjects includes: type 2 diabetes mellitus with more than 10 years duration; having been treated with secretagogues, metformin and insulin in combination with LIRA for at least 6 months; poor glycemic control [glycosylated hemoglobin A1c(HbA1c) 7%-10%]. Totally, twelve patients were enrolled and randomly divided into two groups: the group A (LIRA group, n=6) and the group B (LIRA+ hUC-MSCs group, n=6). The hUC-MSCs were transplanted through infusing of 1×10(6) cells /kg via pancreatic artery directed by interventional radiology on the first day, and followed by infusing 1×10(6) cells /kg through peripheral vein on the eighth, the fifteenth and the twenty-second day sequentially. The control subjects were infused with saline. Both groups were treated with LIRA for 24 weeks at the same period. Fasting plasma glucose(FPG), 2h postprandial plasma glucose(2hPG) and HbA1c were measured. A 75 g oral glucose tolerance test(OGTT)was performed. The early phase of C peptide(CP) secretion function(ΔCP30/ΔG30), the total amount of C peptide secretion function(AUCCP180)and Homeostasis model assessment of insulin resistance (HOMA-IR) were calculated. RESULTS: (1) The baseline FPG, 2hPG, HbA1c, ΔCP30/ΔG30, AUCCP180 andHOMA-IR were comparable between the two groups(P>0.05). (2) Compared with subjects in group A, FPG, 2hPG and HbA1c levels were significantly decreased in subjects in group B [(8.33±0.99) mmol/L vs (6.64±0.79)mmol/L, (13.85±0.86) mmol/L vs (8.65±1.12) mmol/L, (7.82±0.31)% vs (6.82±0.53)%, P<0.05]. (3) Compared with group A, ΔCP30/ΔG30 and AUCCP180 were significantly increased, and HOMA-IR was significantly decreased in group B(0.22±0.13 vs 0.70±0.38, 12.52±5.30 vs 21.16±3.17, 9.46±4.88 vs 4.30±2.68, P<0.05). CONCLUSION:LIRA treatment in combination with hUC-MSCs improves glucose metabolism and the β cell function in type 2 diabetic patients. (ClinicalTrials.gov NCT01954147).
RCT Entities:
OBJECTIVE: To observe the effect of liraglutide (LIRA) in combination of umbilical cord mesenchymal stem cells (hUC-MSCs) in treating type 2 diabetes mellitus. METHODS: Eligibility criteria for subjects includes: type 2 diabetes mellitus with more than 10 years duration; having been treated with secretagogues, metformin and insulin in combination with LIRA for at least 6 months; poor glycemic control [glycosylated hemoglobin A1c(HbA1c) 7%-10%]. Totally, twelve patients were enrolled and randomly divided into two groups: the group A (LIRA group, n=6) and the group B (LIRA+ hUC-MSCs group, n=6). The hUC-MSCs were transplanted through infusing of 1×10(6) cells /kg via pancreatic artery directed by interventional radiology on the first day, and followed by infusing 1×10(6) cells /kg through peripheral vein on the eighth, the fifteenth and the twenty-second day sequentially. The control subjects were infused with saline. Both groups were treated with LIRA for 24 weeks at the same period. Fasting plasma glucose(FPG), 2h postprandial plasma glucose(2hPG) and HbA1c were measured. A 75 g oral glucose tolerance test(OGTT)was performed. The early phase of C peptide(CP) secretion function(ΔCP30/ΔG30), the total amount of C peptide secretion function(AUCCP180)and Homeostasis model assessment of insulin resistance (HOMA-IR) were calculated. RESULTS: (1) The baseline FPG, 2hPG, HbA1c, ΔCP30/ΔG30, AUCCP180 and HOMA-IR were comparable between the two groups(P>0.05). (2) Compared with subjects in group A, FPG, 2hPG and HbA1c levels were significantly decreased in subjects in group B [(8.33±0.99) mmol/L vs (6.64±0.79)mmol/L, (13.85±0.86) mmol/L vs (8.65±1.12) mmol/L, (7.82±0.31)% vs (6.82±0.53)%, P<0.05]. (3) Compared with group A, ΔCP30/ΔG30 and AUCCP180 were significantly increased, and HOMA-IR was significantly decreased in group B(0.22±0.13 vs 0.70±0.38, 12.52±5.30 vs 21.16±3.17, 9.46±4.88 vs 4.30±2.68, P<0.05). CONCLUSION: LIRA treatment in combination with hUC-MSCs improves glucose metabolism and the β cell function in type 2 diabeticpatients. (ClinicalTrials.gov NCT01954147).