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

December 1, 2015 updated by: Charna Dibner, University Hospital, Geneva

Measure and Comparison of Molecular Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • age 20-80
  • consent obtained

Exclusion Criteria:

  • neoplasia
  • inflammatory disease
  • allergy to lidocaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of period length
Time Frame: 5 days
Period length will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of amplitude
Time Frame: 5 days
Amplitude will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 11-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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