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

Sponsor
University Hospital, Geneva (Other)
Overall Status
Unknown status
CT.gov ID
NCT02384148
Collaborator
(none)
300
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Circadian rhythm measurement
  • Procedure: Skin biopsy

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Measure and Comparison of Molecular Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.
Study Start Date :
Jun 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Healthy

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

Other: Circadian rhythm measurement

Procedure: Skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.

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.

Other: Circadian rhythm measurement

Procedure: Skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.

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.

Other: Circadian rhythm measurement

Procedure: Skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.

obese

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

Procedure: Skin biopsy
A 2mm diameter skin biopsy is performed by a physician using standard procedure.

Outcome Measures

Primary Outcome Measures

  1. Difference of period length [5 days]

    Period length will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.

Secondary Outcome Measures

  1. Difference of amplitude [5 days]

    Amplitude will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • age 20-80

  • consent obtained

Exclusion Criteria:
  • neoplasia

  • inflammatory disease

  • allergy to lidocaine

Contacts and Locations

Locations

Site City State Country Postal Code
1 Geneva University Hospital Geneva Switzerland 1205

Sponsors and Collaborators

  • University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Charna Dibner, phD, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT02384148
Other Study ID Numbers:
  • 11-015
First Posted:
Mar 10, 2015
Last Update Posted:
Dec 2, 2015
Last Verified:
Dec 1, 2015

Study Results

No Results Posted as of Dec 2, 2015