Study of Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.
Measure and Comparison of Molecular Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.
1 other identifier
observational
300
1 country
1
Brief Summary
The investigators aimed to characterize human circadian clockwork in healthy individuals in comparison to obese and type 2 diabetic subjects, employing the noninvasive experimental approach allowing the study of circadian profile in human individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedDecember 2, 2015
December 1, 2015
6.5 years
February 27, 2015
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Difference of period length
Period length will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.
5 days
Secondary Outcomes (1)
Difference of amplitude
5 days
Study Arms (4)
Healthy
Healthy volunteers with no inflammation diseases, no neoplasia, no allergy to lidocaine.
Type 2 diabetic non obese
Type 2 diabetic patients with HbA1c\>6.5%, body mass index 19-30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
Type 2 diabetic obese
Type 2 diabetic patients with HbA1c\>6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
obese
Obese non diabetic patients with HbA1c\<6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
Interventions
A 2mm diameter skin biopsy is performed by a physician using standard procedure.
Eligibility Criteria
One hundred normolipidemic healthy individuals, one hundred T2D subjects divided into two sub-groups (T2D non-obese and T2D obese) and one hundred obese non diabetic patients will be included.
You may qualify if:
- age 20-80
- consent obtained
You may not qualify if:
- neoplasia
- inflammatory disease
- allergy to lidocaine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geneva University Hospital
Geneva, 1205, Switzerland
Related Publications (2)
Pagani L, Schmitt K, Meier F, Izakovic J, Roemer K, Viola A, Cajochen C, Wirz-Justice A, Brown SA, Eckert A. Serum factors in older individuals change cellular clock properties. Proc Natl Acad Sci U S A. 2011 Apr 26;108(17):7218-23. doi: 10.1073/pnas.1008882108. Epub 2011 Apr 11.
PMID: 21482780BACKGROUNDBrown SA, Fleury-Olela F, Nagoshi E, Hauser C, Juge C, Meier CA, Chicheportiche R, Dayer JM, Albrecht U, Schibler U. The period length of fibroblast circadian gene expression varies widely among human individuals. PLoS Biol. 2005 Oct;3(10):e338. doi: 10.1371/journal.pbio.0030338. Epub 2005 Sep 27.
PMID: 16167846BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- phD
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 10, 2015
Study Start
June 1, 2011
Primary Completion
December 1, 2017
Last Updated
December 2, 2015
Record last verified: 2015-12