Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01083329
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE March 9, 2010
Last Update Posted Date July 29, 2020
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects
Official Title  ICMJE Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Obese subjects will receive nicotinic acid or placebo for 16 weeks
Study Arms  ICMJE
  • Placebo Comparator: placebo
    for 16 weeks
    Interventions:
    • Behavioral: training
    • Drug: Placebo
  • 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.
    Interventions:
    • Behavioral: training
    • Drug: nicotinic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01083329
Other Study ID Numbers  ICMJE 0816302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claire Thalamas University Toulouse Hospital
PRS Account University Hospital, Toulouse
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP