Leptin Biology in Adipose Tissue

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01800864

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are high in obese subjects indicating resistance to the actions of leptin. High leptin levels have been associated with increased cardiovascular and metabolic risks, but it is not clear if increased leptin or leptin resistance contributes to the increased cardiovascular risk. Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue functions are not completely investigated in humans. Based on preliminary data the investigators hypothesize that resistance to leptin action in obese adipose tissue is responsible for altering the expression of adipose tissue proteins which contribute to the development of cardiovascular and metabolic dysfunction. To test this hypothesis the investigators propose a novel study directed at investigating the leptin dependent changes in adipose tissue protein expression using adipose tissue obtained from lean and obese human subjects

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: obesity	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Leptin Biology in Adipose Tissue

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Normal Normal weight subjects	Other: obesity
Other: Over weight /obese subjects Overweight and obese subjects	Other: obesity

Arm

Intervention/Treatment

Other: Normal

Normal weight subjects

Other: obesity

Other: Over weight /obese subjects

Overweight and obese subjects

Other: obesity

Outcome Measures

Primary Outcome Measures

Changes in adipose tissue protein expression in response to leptin treatment [Baseline and after 24 hours of leptin treatment]
The effect of leptin on adipose tissue protein expression will be assessed by Western blot method. The adipose tissue biopsy samples will be treated with leptin for 24 hours in sterile culture conditions. After leptin treatment, the tissue will be lysed, proteins will be separated by denatured SDS-PAGE electrophoresis, transferred on a nitrocellulose membrane and changes in specific proteins will be determined using protein-specific antibodies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18-75 years
BMI BMI ≤25 (lean) or >30 kg/m2 (obese)
Going to undergo a surgical procedure where omental and subcutaneous adipose tissue may be biopsied.

Exclusion Criteria:

Inability to provide written informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Virend K Somers, MD PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virend Somers, PI, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01800864

Other Study ID Numbers:

11-003834

First Posted:

Feb 28, 2013

Last Update Posted:

Nov 10, 2016

Last Verified:

Nov 1, 2016

Study Results

No Results Posted as of Nov 10, 2016