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

NCT ID: NCT02384148

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Circadian Rhythm Diabetes Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy

Healthy volunteers with no inflammation diseases, no neoplasia, no allergy to lidocaine.

Circadian rhythm measurement

Intervention Type OTHER

Skin biopsy

Intervention Type PROCEDURE

A 2mm diameter skin biopsy is performed by a physician using standard procedure.

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.

Circadian rhythm measurement

Intervention Type OTHER

Skin biopsy

Intervention Type PROCEDURE

A 2mm diameter skin biopsy is performed by a physician using standard procedure.

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.

Circadian rhythm measurement

Intervention Type OTHER

Skin biopsy

Intervention Type PROCEDURE

A 2mm diameter skin biopsy is performed by a physician using standard procedure.

obese

Obese non diabetic patients with HbA1c\<6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.

Circadian rhythm measurement

Intervention Type OTHER

Skin biopsy

Intervention Type PROCEDURE

A 2mm diameter skin biopsy is performed by a physician using standard procedure.

Interventions

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Circadian rhythm measurement

Intervention Type OTHER

Skin biopsy

A 2mm diameter skin biopsy is performed by a physician using standard procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 20-80
* consent obtained

Exclusion Criteria

* neoplasia
* inflammatory disease
* allergy to lidocaine
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Charna Dibner

phD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Geneva University Hospital

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 21482780 (View on PubMed)

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. doi: 10.1371/journal.pbio.0030338. Epub 2005 Sep 27.

Reference Type BACKGROUND
PMID: 16167846 (View on PubMed)

Other Identifiers

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11-015

Identifier Type: -

Identifier Source: org_study_id