Study of Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.

Obesity Clinical Trial

Official title:

Measure and Comparison of Molecular Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02384148
• Other study ID #: 11-015
• Status: Active, not recruiting
• Phase: N/A
• First received: February 27, 2015
• Last updated: December 1, 2015
• Start date: June 2011

Study information

• Verified date: December 2015
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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.

Description:

The investigators specifically aim to obtain and analyze the circadian profile of skin fibroblasts from healthy, obese and T2D subjects. Does circadian oscillator profile and its parameters (phase, period and amplitude) will differ between healthy individuals and obese/ T2D patients? Skin biopsy will be performed in order to collect and culture skin fibroblast cells.

In vivo bioluminescence recording will be performed in primary human skin fibroblast cells. The profiles obtained from 10 subjects in each group will be compared to their healthy counterparts.

Bmal1and Per2 are clock genes. Lentiviral transduction of Bmal1-luciferase or Per2-luciferase in fibroblasts allow observation of circadian oscillations using bioluminescence assay. Phase, period length and amplitude are used to characterize the circadian rhythm.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 20-80

• consent obtained

Exclusion Criteria:

• neoplasia

• inflammatory disease

• allergy to lidocaine

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Circadian Rhythm
• Diabetes
• Obesity

Intervention

Other:
• Circadian rhythm measurement

Procedure:
• Skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Brown 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. Epub 2005 Sep 27. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of period length	Period length will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.	5 days	No
Secondary	Difference of amplitude	Amplitude will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.	5 days	No