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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadian rhythm measurement | Other |
| ||
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of amplitude | Amplitude will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospital | Geneva | 1205 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21482780 | Background | 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. | |
| 16167846 | Background | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Skin biopsy |
| Procedure |
A 2mm diameter skin biopsy is performed by a physician using standard procedure. |
|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |