Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Brief summary
Stem cells have promising potential in treating diabetes. However the therapeutic outcome in diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.
Detailed description
Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.
Interventions
PROCEDUREstem cells
stem cell will be injected
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • Patients with type 2 diabetes mellitus between 30 and 65 years of age. * Duration of diabetes ≥ 5 years. * Failure to triple OHA in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}. * Requiring insulin therapy for last six month * On stable doses of insulin (≥0.4 IU/kg/day, Vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months. * GAD antibody negative status.
Exclusion criteria
* Patients with type 1 diabetes mellitus or secondary diabetes * Patients with serum creatinine \> 1.5 mg/dL * 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). * History of cholecystitis/ cholelithiasis/ cholecystectomy. * Seropositivity for HIV, HBsAg and HCV. * History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in glucagon stimulated C peptide level | 6 months |
Outcome results
None listed