- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01800864
Leptin Biology in Adipose Tissue
November 8, 2016 updated by: Virend Somers, Mayo Clinic
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
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
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
-
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Normal
Normal weight subjects
|
|
Other: Over weight /obese subjects
Overweight and obese subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in adipose tissue protein expression in response to leptin treatment
Time Frame: 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.
|
Baseline and after 24 hours of leptin treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Virend K Somers, MD PhD, Mayo Clinic
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
August 1, 2011
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
February 26, 2013
First Submitted That Met QC Criteria
February 27, 2013
First Posted (Estimate)
February 28, 2013
Study Record Updates
Last Update Posted (Estimate)
November 10, 2016
Last Update Submitted That Met QC Criteria
November 8, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 11-003834
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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