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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02384148

Enrollment

300

Registered

2015-03-10

Start date

2011-06-30

Completion date

Unknown

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm, Diabetes, Obesity

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.

Detailed 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.

Interventions

OTHERCircadian rhythm measurement

PROCEDURESkin biopsy

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* age 20-80 * consent obtained

Exclusion criteria

* neoplasia * inflammatory disease * allergy to lidocaine

Design outcomes

Primary

Measure	Time frame	Description
Difference of period length	5 days	Period length will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.

Secondary

Measure	Time frame	Description
Difference of amplitude	5 days	Amplitude will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026