Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus

Post Graduate Institute of Medical Education and Research, Chandigarh21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes