Status:
COMPLETED
Comparison of Hematopoietic Stem Cell Activity in Adipose Tissue From Type 2 Diabetic Patients and Healthy Volunteers
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Type2 Diabetes
Eligibility:
MALE
37-63 years
Phase:
NA
Brief Summary
Based on solid preclinical results in mice and preliminary data in humans, this study aims to provide the proof of concept of the crucial role of the hematopoietic process occurring in human adipose t...
Detailed Description
In mice, increasing data demonstrate a causal relationship between the inflammatory process in adipose tissue and the development of insulin resistance, resulting in type 2 diabetes occurrence. Howeve...
Eligibility Criteria
Inclusion
- No major weight variation for at least 3 months
- Biological assessment without clinically significant anomaly from the point of view of the investigator.
- Acceptance of constraints related to participation in the study
- Acceptance of participation in the constitution of a cell bank, a tissue bank and a serum library.
- Affiliation to a social security scheme.
- Type 2 diabetic subjects:
- Type 2 diabetes (discovered after the age of 35 years, without inaugural ketosis and absence of insulin therapy during the first year).
- 40 to 60 year-old.
- BMI between 27 and 35 kg / m² (included).
- Treated by modification of lifestyle alone or associated to oral anti-diabetic therapy only.
- With stable oral anti-diabetic treatment for at least 3 months.
- HbA1c ≤ 8.5%.
- Healthy Volunteers:
- BMI between 23 and 27 kg / m² (included).
- 37 to 63 year-old, age-matched to a type 2 diabetes subject ± 5 years.
- Fasting blood glucose \< 1,10 g / L.
- HbA1c within normal limits (4 to 6%).
Exclusion
- Excessive chronic alcohol consumption (\> 30 g / day or 210 g / week).
- Tobacco consumption\> 10 cigarettes / day that cannot be stopped for 24 hours.
- Anti-diabetic treatments that require sub-cutaneous injections
- History of chronic or acute hematological pathology.
- Systemic or acute inflammatory pathology.
- Treatment with antiplatelet agents, non-steroidal anti-inflammatory drugs, glucocorticoids (excluding eye drops and sprays), or other immunosuppressive drugs.
- History of cancer (except basal cell carcinoma).
- Allergy to xylocaine or one of its derivatives.
- Any significant pathology at the discretion of the investigator.
- Any biological anomaly at the discretion of the investigator.
- Positive human immunodeficiency virus serology.
- Positive hepatitis B serology.
- Positive hepatitis C serology.
- Glomerular filtration rate less than 60 ml / min
- Aspartate aminotransferase or alanine aminotransferase higher than 2.5-fold the upper normal value.
- Hypertriglyceridemia \> 2.5 g / l
- Person under the protection of justice, guardianship or curators.
- Subject involved in another research protocol or in an exclusion period from another research protocol.
- Cognitive disorder or mental pathology (at the discretion of the investigator).
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03260452
Start Date
June 28 2018
End Date
January 24 2019
Last Update
April 2 2019
Active Locations (1)
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1
CHU de Toulouse - Rangueil
Toulouse, France, 31059