Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
Detailed description
We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(\>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that ABMSCT in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a microenvironment which supports beta cell/resident stem cell activation and survival.
Interventions
BIOLOGICALstem cell transplantation
Group 1: 200 - 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - Hyperaque) and stem cells will be separated. Separated MNC's will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of \>40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with type 2 diabetes mellitus between 30 and 70 years of age. 2. Failure to triple OHA and on stable doses of insulin for atleast 3 months. 3. On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia. 4. HbA1c \< 8.5%. 5. Insulin requirement ≥0.4 IU/kg/d. 6. GAD antibody negative status.
Exclusion criteria
1. Patients with T1DM or secondary diabetes. 2. Patients with serum creatinine \> 1.5 mg/dl. 3. Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory). 4. History of cholecystitis/ cholelitiasis/ cholecystectomy 5. Seropositivity for HIV, HBsAg and HCV. 6. History of myocardial infarction or unstable angina in the previous 3 months. 7. History of malignancy 8. Patients with active infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels . | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls. | 6 months |
Countries
India
Outcome results
None listed