NCT01083329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Jan 2010

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

February 25, 2010

Last Update Submit

July 28, 2020

Conditions

Obesity

Keywords

nicotinic acidlipolysistraining programadipose tissue inflammationobese

Outcome Measures

Primary Outcomes (1)

  • Comparison of changes of AT inflammation will be measured by gene expression analysis

    Visit 1(T0), Visit 2 (T+8 weeks of treatment) and Visit 3 (T+16 weeks of treatment)

Secondary Outcomes (1)

  • Comparison of changes in insulin sensitivity and glucose tolerance

    Visit 1(T0), Visit 2 (T+8 weeks of treatment) and Visit 3 (T+16 weeks of treatment)

Study Arms (2)

placebo

PLACEBO COMPARATOR

for 16 weeks

Behavioral: trainingDrug: Placebo

nicotinic acid

ACTIVE COMPARATOR

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: trainingDrug: nicotinic acid

Interventions

trainingBEHAVIORAL

the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid

nicotinic acidplacebo
nicotinic acidDRUG

Obese subjects will receive nicotinic acid or placebo for 16 weeks

nicotinic acid
PlaceboDRUG

Obese subjects will receive nicotinic acid or placebo for 16 weeks

placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique, Purpan University Toulouse Hospital

Toulouse, 31059, France

Location

Related Publications (2)

  • Montastier E, Beuzelin D, Martins F, Mir L, Marques MA, Thalamas C, Iacovoni J, Langin D, Viguerie N. Niacin induces miR-502-3p expression which impairs insulin sensitivity in human adipocytes. Int J Obes (Lond). 2019 Jul;43(7):1485-1490. doi: 10.1038/s41366-018-0260-5. Epub 2018 Nov 27.

    PMID: 30482933RESULT

  • Bourlier V, Saint-Laurent C, Louche K, Badin PM, Thalamas C, de Glisezinski I, Langin D, Sengenes C, Moro C. Enhanced glucose metabolism is preserved in cultured primary myotubes from obese donors in response to exercise training. J Clin Endocrinol Metab. 2013 Sep;98(9):3739-47. doi: 10.1210/jc.2013-1727. Epub 2013 Jul 24.

    PMID: 23884778DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Niacin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Claire Thalamas

    University Toulouse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 9, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2012

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

FR(1)