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eukocyte dynamics in health and disease: in vivo labelling of dividing leukocytes using deuterated water

Withdrawn
Conditions
lymfopenie ten gevolge van stamceltransplantatie
lymphopenia
immune cell loss
10021460
Registration Number
NL-OMON33432
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

a. healthy, 20-30 years of age, HIV-negative confirmed with an HIV-test
b. healthy, 60 years or older, HIV-negative confirmed with an HIV-test
c. healthy, 18 years or older, complete thymus removed at young age because of heart surgery, HIV-negative confirmed with an HIV-test
d. stem cell transplantation patiënt, 18 years or older, treated for lymphoma with an autologous HSCT, HIV-negative confirmed with an HIV-test
e. 18 years or older, HIV-1-infected, untreated before and during the study

Exclusion Criteria

Participants will be asked to answer a questionnaire which informs us about their health status. Exclusion criteria for each group separately:
a. (i) heart- and/or kidney problems, (ii) immunologic disorder (iii) diabetes, (iv) blood transfusion within the last 6 months, (v) hormone therapy within the last 6 months, (vi) transplantation, (vii) vaccination within the last 4 weeks, (viii) infection and/or fever within the last 4 weeks, (ix) surgery within the last 4 weeks, (x) severe allergy, (xi) for women: pregnancy or parent's wish in the coming year (xii) excessive alcoholic consumption or excessive drug use
b. (i) heart- and/or kidney problems, (ii) immunologic disorder (iii) diabetes, (iv) blood transfusion within the last 6 months, (v) hormone therapy within the last 6 months, (vi) transplantation, (vii) vaccination within the last 4 weeks, (viii) infection and/or fever within the last 4 weeks, (ix) surgery within the last 4 weeks, (x) severe allergy, (xi) excessive alcoholic consumption or excessive drug use
c. (i) heart- and/or kidney problems, (ii) diabetes, (iii) blood transfusion within the last 6 months, (iv) hormone therapy within the last 6 months, (v) transplantation, (vi) vaccination within the last 4 weeks, (vii) infection and/or fever within the last 4 weeks, (viii) surgery within the last 4 weeks, (ix) severe allergy, (x) for women: pregnancy or parent's wish in the coming year (xii) excessive alcoholic consumption or excessive drug use
d. (i) transplantation-related complications, (ii) severe infections (iii) heart- and/or kidney problems, (iv) diabetes, (v) hormone therapy within the last 6 months, (vi) vaccination within the last 4 weeks, (vii) severe allergy, (viii) for women: pregnancy or parent's wish in the coming year (ix) excessive alcoholic consumption or excessive drug use
e. (i) treatment with antiretroviral therapy or expectancy of treatment in the coming year (ii) heart- and/or kidney problems, (iii) diabetes, (iv) blood transfusion within the last 6 months, (v) hormone therapy within the last 6 months, (vi) transplantation, (vii) vaccination within the last 4 weeks, (viii) surgery within the last 4 weeks, (ix) severe allergy, (x) for women: pregnancy or parent's wish in the coming year (xi) excessive alcoholic consumption or excessive drug use

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p> The main parameter of the study is the amount of deuterium (label) that the<br /><br>different leukocyte populations have incorporated in their DNA by cell division<br /><br>at a given time. For this purpose blood withdrawals are done both in the period<br /><br>during which participants drink 2H2O (uplabelling phase), and in the period<br /><br>after stopping with 2H2O intake (delabelling phase). Data obtained during<br /><br>uplabelling and delabelling phases can be interpreted by mathematical models<br /><br>that describe the dynamics of leukocyte populations. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>With the obtained materials several in vitro immunological tests will be<br /><br>performed, including determination of blood- and plasma levels and analysis of<br /><br>cell phenotypes and cell numbers within subpopulations. </p><br>
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