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

• Conditions: Diabetes; Circadian Rhythm; Obesity
• Interventions: Other: Circadian rhythm measurement; Procedure: Skin biopsy

• Registration Number: NCT02384148
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• age 20-80
• consent obtained

Exclusion Criteria

• neoplasia
• inflammatory disease
• allergy to lidocaine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Circadian rhythm measurement	Healthy volunteers with no inflammation diseases, no neoplasia, no allergy to lidocaine.
obese	Skin biopsy	Obese non diabetic patients with HbA1c\<6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
Type 2 diabetic non obese	Skin biopsy	Type 2 diabetic patients with HbA1c\>6.5%, body mass index 19-30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
Type 2 diabetic obese	Circadian rhythm measurement	Type 2 diabetic patients with HbA1c\>6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
Type 2 diabetic obese	Skin biopsy	Type 2 diabetic patients with HbA1c\>6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
Healthy	Skin biopsy	Healthy volunteers with no inflammation diseases, no neoplasia, no allergy to lidocaine.
Type 2 diabetic non obese	Circadian rhythm measurement	Type 2 diabetic patients with HbA1c\>6.5%, body mass index 19-30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
obese	Circadian rhythm measurement	Obese non diabetic patients with HbA1c\<6.5%, body mass index \>30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Geneva University Hospital; 🇨🇭 Geneva, Switzerland