ObesityPhase 2ANITANCT01083329
Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects
A Phase 2 study testing training and nicotinic acid in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- training and nicotinic acid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique, Purpan University Toulouse Hospital
Toulouse, 31059
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- training, nicotinic acid, Placebo
- Keywords
- nicotinic acid, lipolysis, training program, adipose tissue inflammation, obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingBehavioural
the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid
nicotinic acidDrug
Obese subjects will receive nicotinic acid or placebo for 16 weeks
PlaceboDrug
Obese subjects will receive nicotinic acid or placebo for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | for 16 weeks Receives: Behavioral: training; Drug: 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. Receives: Behavioral: training; Drug: nicotinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of changes of AT inflammation will be measured by gene expression analysis
Measured: 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
Measured: Visit 1(T0), Visit 2 (T+8 weeks of treatment) and Visit 3 (T+16 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Thalamas, Principal investigator, University Toulouse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083329
- Sponsor's protocol ID
- 0816302
- Acronym
- ANITA
- Status last verified
- Jul 2020
- First submitted
- 25 Feb 2010
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30482933Bourlier 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.
PubMed 23884778
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects
- ClinicalTrials.gov ID
- NCT01083329
- Acronym / sponsor ID
- ANITA / 0816302
- Conditions
- Obesity
- Keywords
- nicotinic acid, lipolysis, training program, adipose tissue inflammation, obese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Behavioral: training, Drug: Placebofor 16 weeks |
| nicotinic acid | Active comparator | Behavioral: training, Drug: nicotinic acidfor 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trainingthe last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid | Behavioural | nicotinic acid, placebo |
| nicotinic acidObese subjects will receive nicotinic acid or placebo for 16 weeks | Drug | nicotinic acid |
| PlaceboObese subjects will receive nicotinic acid or placebo for 16 weeks | Drug | placebo |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Results publication: PubMed 30482933Montastier 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.
- Derived from this study: PubMed 23884778Bourlier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Thalamas principal investigator
University Toulouse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing training and nicotinic acid in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01083329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.