Inflammation Regulation in Obese Patients
Relations Between Obesity and Insulin Resistance: Role of Inflammation Regulatory Mechanisms in Obese Patients Without Associated Comorbidity
1 other identifier
interventional
30
1 country
1
Brief Summary
Insulin resistance is one of the main mechanisms involved in metabolic diseases. inflammation has been implicated in its pathogenesis, due to innate immunity activation by free fatty acids, lipopolysaccharides (LPS) and lactate. Free fatty acids, LPS and lactate activate innate immunity in squelettal muscle and adipose tissue via Toll-like receptor 2/4, NFkB, IRF3 (Interferon Responsive Factor 3) and cytokines secretion (TNFa, IFN g, IL1b, IL6), chemokines secretion (MCP1) and leukotrienes (LTB4). Feed back mechanisms involved in TLR signaling pathways as RLI (ribonuclease L inhibitor)/ABCE1, have never been studied in inflammation due to obesity. RLI inhibits an endoribonuclease, RNase L, which has been recently implicated in TLR signaling The purpose of this study is to analyse the role of RLI and RNase L in TLR regulation, and its potential implication in the link between obesity, inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 6, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 18, 2015
March 1, 2012
Same day
March 6, 2012
September 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TLR regulation
analyse the role of RLI and RNase L in TLR regulation, and its potential implication in the link between obesity, microinflammation and insulin resistance in adipose tissue and squelettal muscle in humans.
2 years
Study Arms (3)
volunteers
ACTIVE COMPARATORnot overweight Volunteers responding to the study criteria
overweight patients insulin sensitive
EXPERIMENTALoverweight patients insulin sensitive responding to the study criteria
overweight insulin resistant
EXPERIMENTALoverweight patients insulin resistant responding to the study criteria
Interventions
muscle and fat biopsy
Eligibility Criteria
You may qualify if:
- Age between 50 and 65 years old
- Men/ menopausal women
- BMI \<25 kg/m2 for the control group, BMI \>30 kg/m2 for the obese group
- Non diabetic patients
- HOMAIR \<3 for the insulin sensitive obese group
- Non smoking
- Without any inflammatory disease
- Without any first degrees relative with diabetes
- Without any treatment that could interfere with insulin sensitivity
- without any infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montpellier University Hospital
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jacques Mercier
University Hospital, Montpellier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2012
First Posted
March 23, 2012
Study Start
November 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2013
Last Updated
September 18, 2015
Record last verified: 2012-03