Leptin Biology in Adipose Tissue

NCT01800864 | Completed

• 1 other identifier: 11-003834
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in adipose tissue protein expression in response to 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.

  Baseline and after 24 hours of leptin treatment

Study Arms (2)

Normal

OTHER

Normal weight subjects

Other: obesity

Over weight /obese subjects

OTHER

Overweight and obese subjects

Other: obesity

Interventions

obesity OTHER

Normal; Over weight /obese subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide written informed consent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Officials

• Virend K Somers, MD PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: August 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

US (1)