Hyperglycemia, Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus Type 2, Hyperglycemia, Immunotherapy, Autologous
Brief summary
Diabetes mellitus type 2 is a long-term metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency and hyperglycemia. Our hypotheses is that liver would be the primary organ responsible for the metabolic disorder because of some unknown defects, where sugar would not be efficiently converted to glycogen and fat, leading to hyperglycemia. The constant hyperglycemia would keep pressure on beta-cells in the pancreas to eventually exhaust their ability to produce and secret sufficient amount of insulin, exacerbating the disease. The Immunotherapy would enhance the liver functions and correct the abnormal sugar metabolism. In addition, the ex vivo activated cells produce and secret growth factors which would help endothelial cells of blood vessels to reproduce and grow, resulting in reduced arteriosclerosis.
Detailed description
We plan to recruit 20 patients with type 2 diabetes mellitus who suffer hyperglycemia with or without medication. The patients will come to our hospitals for the treatment. A small amount of peripheral blood will be drawn and processed and cultured in our laboratory. The cultured cells (autologous) will be infused intravenously back to patients. Levels of plasma hemoglobin A1c (HbA1c) and other metabolic parameters before and after the therapy will be compared. The therapy is planned to take four weeks for each patient.
Interventions
DRUGex vivo Activated Immune Cells
The patients who take medication before the enrollment will be required to reduce at least half the amount of the medication before the treatment. The reduction of the medication will continue during and after the therapy until the levels of plasma hemoglobin A1c (HbA1c) increase to equal or above the levels of the baseline measured before the treatment.
Sponsors
Guangzhou No.12 People's Hospital
The 12th People's Hospital of Shenzhen City
B & Y Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Patients diagnosed with type 2 diabetes mellitus. * 2\. 25 years of age or older. Both sexes. * 3\. HbA1c ≧6.5% for more than 6 months with or without medication. * 4\. Capability of providing informed consent.
Exclusion criteria
* 1\. History of malignancy. * 2\. Patients with active infections. * 3\. Seropositivity for HIV infection. * 4\. History of myocardial infarction or unstable angina in the previous 3 months. * 5\. Pregnancy or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline Hemoglobin A1c (HbA1c) at up to 27 weeks. | Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Lipid Profile at up to 27 weeks. | Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks. | Lipid profile includes cholesterol, triglycerides, HDL cholesterol and LDL cholesterol. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Symptoms at up to 27 weeks. | Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks. | The symptoms include insomnia, anorexia, fatigue, frequent trips to the bathroom, unquenchable thirst and blurred vision. |
Countries
China
Outcome results
None listed