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

Study Overview
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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.

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

Conditions
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Circadian Rhythm, Diabetes, Obesity

Intervention / Treatment
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* Other: Circadian rhythm measurement
* Procedure: Skin biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20-80 consent obtained Exclusion Criteria: neoplasia inflammatory disease allergy to lidocaine

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Healthy volunteers with no inflammation diseases, no neoplasia, no allergy to lidocaine. | Other: Circadian rhythm measurement<br> <br> Procedure: Skin biopsy<br>* A 2mm diameter skin biopsy is performed by a physician using standard procedure.<br>|
| Type 2 diabetic non obese<br>Type 2 diabetic patients with HbA1c>6.5%, body mass index 19-30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine. | Other: Circadian rhythm measurement<br> <br> Procedure: Skin biopsy<br>* A 2mm diameter skin biopsy is performed by a physician using standard procedure.<br>|
| Type 2 diabetic obese<br>Type 2 diabetic patients with HbA1c>6.5%, body mass index >30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine. | Other: Circadian rhythm measurement<br> <br> Procedure: Skin biopsy<br>* A 2mm diameter skin biopsy is performed by a physician using standard procedure.<br>|
| obese<br>Obese non diabetic patients with HbA1c<6.5%, body mass index >30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine. | Other: Circadian rhythm measurement<br> <br> Procedure: Skin biopsy<br>* A 2mm diameter skin biopsy is performed by a physician using standard procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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