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

University Hospitals (UH)

Status: Unknown

Conditions: Diabetes; Circadian Rhythm; Obesity

Treatments: Procedure: Skin biopsy; Other: Circadian rhythm measurement

Study type: Observational

Funder types: Other

Identifiers

NCT02384148

11-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 20-80
• consent obtained

Exclusion criteria

• neoplasia
• inflammatory disease
• allergy to lidocaine

Trial design

300 participants in 4 patient groups

Healthy

Description:

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

Treatment:

Procedure: Skin biopsy

Other: Circadian rhythm measurement

Type 2 diabetic non obese

Description:

Type 2 diabetic patients with HbA1c\>6.5%, body mass index 19-30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.

Treatment:

Procedure: Skin biopsy

Other: Circadian rhythm measurement

Type 2 diabetic obese

Description:

Type 2 diabetic patients with HbA1c\>6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.

Treatment:

Procedure: Skin biopsy

Other: Circadian rhythm measurement

obese

Description:

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

Treatment:

Procedure: Skin biopsy

Other: Circadian rhythm measurement