Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects (ANITA)

July 28, 2020 updated by: University Hospital, Toulouse

Our working hypothesis postulates that lipolysis is a determinant of inflammation in adipose tissue (AT). Inhibition of lipolysis, e.g. using the oldest normolipidemic drug, nicotinic acid, has proved valuable to combat the metabolic syndrome. Our proposal will determine whether part of the beneficial effects of this antilipolytic compound is due to a diminution of AT inflammation.

To this aim, the effect of nicotinic acid or placebo will be studied in male obese subjects with or without a training program which goal is to enhance lipolysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

24 male obese insulin resistant subjects will receive nicotinic acid or placebo for 16 weeks. The last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid. Insulin sensitivity and glucose tolerance will be assessed using, respectively, fasting-based estimates of insulin sensitivity (plasma and muscle) and oral glucose tolerance test. Plasma parameters of adipokines and, inflammatory and metabolic parameters will be determined. As an index of AT inflammation, the percentage and the phenotype of macrophages will be determined using flow cytometry of cells of the stromavascular fraction of subcutaneous AT. Macrophage infiltration will be investigated by light microscopy. The characterization of the inflammatory profile of AT will be completed by measurements of the expression of genes that are either specific markers of human AT macrophages or inflammatory and anti-inflammatory adipokines. This combination of approaches has never been carried out during a pharmacological intervention in humans. The following points will be addressed:

  • determine the influence of lipolysis on AT inflammation, specifically on macrophage activation and adipokine production.
  • examine the causal relationship between adipocyte FA metabolism, AT inflammation and insulin sensitivity.
  • establish whether the beneficial effect of antilipolytic drugs may be attributable at least in part to a decrease in AT inflammation.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

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

  • France
      • Toulouse, France, 31059
        • Centre d'Investigation Clinique, Purpan University Toulouse Hospital

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Signature of informed consent form
  • Age 25 to 45 year-old
  • Male, insulin resistant obese subjects (30<BMI<40 kg/m2),
  • Blood arterial pressure<140/90 mmHg

Exclusion Criteria:

  • History of cardiovascular disease
  • Treatment with drugs which can interfere with cardiovascular system and autonomic nervous system (i.e. beta blockers).
  • Treatment with nicotinic acid
  • Treatment with fibrates, statins, cholestyramine and ezetimibe
  • Treatment with thiazidics
  • Fasted hyperglycaemia > 1,26 g/l (Diabetes)
  • Triglycerides >5 g/l
  • Blood arterial pressure > 140/90 mm Hg

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
for 16 weeks
Behavioral: training
the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid
Drug: Placebo
Obese subjects will receive nicotinic acid or placebo for 16 weeks
Active Comparator: nicotinic acid

for 16 weeks :

  • week 1 = 375 mg per day,
  • week 2 = 500 mg per day,
  • week 3 = 750 mg per day,
  • week 4 = 1000 mg per day,
  • week 5 = 1500 mg per day,
  • weeks 6 to 16 = 2000 mg per day.
Behavioral: training
the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid
Drug: nicotinic acid
Obese subjects will receive nicotinic acid or placebo for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of changes of AT inflammation will be measured by gene expression analysis
Time Frame: Visit 1(T0), Visit 2 (T+8 weeks of treatment) and Visit 3 (T+16 weeks of treatment)
Visit 1(T0), Visit 2 (T+8 weeks of treatment) and Visit 3 (T+16 weeks of treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of changes in insulin sensitivity and glucose tolerance
Time Frame: Visit 1(T0), Visit 2 (T+8 weeks of treatment) and Visit 3 (T+16 weeks of treatment)
Visit 1(T0), Visit 2 (T+8 weeks of treatment) and Visit 3 (T+16 weeks of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Claire Thalamas, University Toulouse Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0816302

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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