Assessment of Insulin Sensitivity and β Cell Function by Clamps Studies
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ClinicalTrials.gov Identifier: NCT02662400 |
Recruitment Status :
Completed
First Posted : January 25, 2016
Last Update Posted : January 18, 2017
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Non-Insulin-Dependent | Biological: MNCs | Phase 2 Phase 3 |
The shortcomings can be overcome by the use of stem cells which is an inexhaustible source of β -cells. Stem cells are primitive cells capable of differentiating into mature cells of the body of various lineages. Stem cells can be obtained from various sources like blastocyst (embryonal stem cells), umbilical cord or bone marrow. There is an evidence to suggest that stem cell transplantation can lead to improvement in pancreatic endocrine function and improvement in glycemic control in diabetic mice through various mechanisms such as transdifferentiation or regeneration of endothelial cell in the damaged islets which in turn lead to regeneration of islet cells by paracrine action. However, till date there is no study that demonstrates that stem cell therapy can be effective in patients with T2DM for their glycemic control.
The investigators propose to carry out autologous bone marrow - derived stem cell transplantation (ABMSCT) in patients of T2DM, obtained from their own bone marrow and its superselective injection into the gastroduodenal artery after purification without any immunosuppressive regimen.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Assessment of Insulin Sensitivity and β Cell Function by Clamps Studies After Stem Cell Transplantation in T2DM |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
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Experimental: MNCs GROUP
Patients with Type 2 Diabetes mellitus
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Biological: MNCs
200 - 300 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - hypaque ) and stem cells will be separated. Separated mono nucleated cells will injected into superior pancreatico duodenal artery. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , AND EUGLYCEMIC CLAMP TO ASSESS INSULIN SENSITIVITY .Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months |
- Improvement in insulin sensitivity after stem cell transplantation [ Time Frame: 6 months ]Stem cells will be transplanted in patients with T2DM. Pre and Pro stem cell transplantation Insulin sensitivity(pmol/l) will be assessed by euglycemic clamp .
- Improvement in β cell function after stem cell transplantation [ Time Frame: 6 months ]Stem cells will be transplanted in patients with T2DM. Pre and Pro stem cell transplantation β cell function(nmol/L) will be assessed by hyperglycemia clamp .

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Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Failure to triple oral hypoglycemic agent and on stable doses of insulin for at least 3 months.
- On vildagliptin,pioglitazone and metformin for at least 3 months along with Insulin to maintain euglycemia.
- HbA1c < 7.5%.
- Insulin requirement ≥0.4 IU/kg/d.
- 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 hepatitis C virus (HCV).
- History of myocardial infarction or unstable angina in the previous 3 months.
- History of malignancy.
- Patients with active infections.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662400
Principal Investigator: | anil Bhansali, DM | Postgraduate Institute of Medical Education and Research |
Responsible Party: | Anil Bhansali, Profeesor, Postgraduate Institute of Medical Education and Research |
ClinicalTrials.gov Identifier: | NCT02662400 |
Other Study ID Numbers: |
MNCs IN Diabetes |
First Posted: | January 25, 2016 Key Record Dates |
Last Update Posted: | January 18, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Insulin Resistance Diabetes Mellitus, Type 2 Hyperinsulinism Glucose Metabolism Disorders |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |