Overview

This trial is active, not recruiting.

Conditions circadian rhythm, diabetes, obesity
Treatments circadian rhythm measurement, skin biopsy
Sponsor University Hospital, Geneva
Start date June 2011
End date December 2017
Trial size 300 participants
Trial identifier NCT02384148, 11-015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
Healthy volunteers with no inflammation diseases, no neoplasia, no allergy to lidocaine.
circadian rhythm measurement
skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.
Type 2 diabetic patients with HbA1c>6.5%, body mass index 19-30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
circadian rhythm measurement
skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.
Type 2 diabetic patients with HbA1c>6.5%, body mass index >30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
circadian rhythm measurement
skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.
Obese non diabetic patients with HbA1c<6.5%, body mass index >30 kg/m2, no inflammation diseases, no neoplasia, no allergy to lidocaine.
circadian rhythm measurement
skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.

Primary Outcomes

Measure
Difference of period length
time frame: 5 days

Secondary Outcomes

Measure
Difference of amplitude
time frame: 5 days

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Measure and Comparison of Molecular Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.