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Leptin Biology in Adipose Tissue

NCT ID: NCT01800864

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal

Normal weight subjects

Group Type OTHER

obesity

Intervention Type OTHER

Over weight /obese subjects

Overweight and obese subjects

Group Type OTHER

obesity

Intervention Type OTHER

Interventions

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obesity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Inability to provide written informed consent.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Virend Somers

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virend K Somers, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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11-003834

Identifier Type: -

Identifier Source: org_study_id