Insulin SensitivityNCT01216956
Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
A study of Insulin Sensitivity and Lipoproteins Metabolism, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
Trial summary
Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Insulin Sensitivity, Lipoproteins Metabolism, Non Esterified Fatty Acid Kinetics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Mar 2010
- Phase
- Interventional
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waist circumference > 94cm
- Triglyceride concentration between 150mg/dL and 400mg/dL
- HDL-c < 60mg/dL
- Body mass index: 27 to 35 kg/m²
Who cannot join
- cancer
- diabetes mellitus
- hepatic, renal or digestive disorder
- hypertension
- chronic medical treatment interfering on lipids parameters
Trial locations and contacts
1 site in 1 country.
About this study
Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the drug has been used for so long, its precise mechanism of action remains elusive. The aim of this study was to characterise the metabolic changes induced by 8 week treatment with Niacin in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. In order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.
Read the detailed description
24 patients will be included in a double blind placebo controlled cross-over 8 week study comparing placebo to Niaspan (a long release formulation of niacin). In order to prevent any drop out linked to the flushing side effect of niacin, patient will take aspirin (300mg) prior to treatment throughout the study duration. The study will include at start and end of each arm, a full lipoproteins quantification as well as a measure of enzymes involved in lipid metabolism. On day 42 and 56 of each period, after an administration of either placebo or 500mg of immediate release niacin respectively, changes in plasma free fatty acid levels will be measured for 8hours in order to assess potential loss of activity of niacin over time upon chronic treatment with niaspan. Half of the patient will have an exploration of their glucose metabolism using hyperinsulinic clamp technique, whereas in the other half a metabolic turnover study using stable isotopes will focus on their lipoproteins, triglycerides and cholesterol handling. These explorations will be done at the end of each treatment period.
- Conditions
- Insulin Sensitivity, Lipoproteins Metabolism, Non Esterified Fatty Acid Kinetics, Lipid Profile
- Being tested
- Extended-release nicotinic acid versus placebo
- Keywords
- extended release nicotinic acid, non esterified fatty acid (NEFA), insulin resistance, Cholesteryl ester transfer protein (CETP), High density lipoprotein cholesterol
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release nicotinic acid versus placeboDrug
Voluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite.
| Study group | Role | What they receive |
|---|---|---|
| Extended release nicotinic acid | Experimental | Not described Receives: Drug: Extended-release nicotinic acid versus placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Extended-release nicotinic acid versus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of non-esterified fatty acid and triglycerides concentrations over time
Twelve hours after ingestion of chronic treatment, measures of non esterified fatty acid and triglycerides concentrations were carried out during 480 minutes to assess acute and chronic treatment effect on lipolysis and on triglyceride concentration.
To appreciate both acute and chronic effects, subjects received medicinal supplements in addition to their chronic treatment:
- On day 42, 500 mg of placebo to assess chronic nicotinic acid effect versus placebo effect
- On day 56, 500 mg of immediate-release nicotinic acid (INA) to assess acute versus chronic nicotinic acid effect.
Measured: After 42 and 56 days of placebo or nicotinic acid treatment
Secondary outcomes (3)
Insulin sensitivity after treatment
Euglycemic Hyperinsulinemic clamp with glucose tracer infusion
Measured: After 53 days of placebo or nicotinic acid treatment
Lipoproteins metabolism
Stable Isotopic tracer infusion (d3-leucine, 13C-acétate, d5-glycerol)
Measured: After 53 days of placebo or nicotinic acid treatment
Lipid profile
Measure of lipoproteins (VLDL, IDL, LDL, HDL) - characterization of lipoprotein's subfraction Measure of enzymatic activity of cholesteryl ester transfer protein (CETP), phospholipid transfer protein (PLTP) and lecithin cholesterol acyl transferase (LCAT)
Measured: Before and after placebo or nicotinic acid treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startSep 2006
- Primary completionJun 2009
- Study completionMar 2010
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 Insulin SensitivityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Sponsor type
- University, hospital or other
- Investigators
- Michel Krempf, PhD, MD, Principal investigator, Institut National de la Santé Et de la Recheche Médiacle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216956
- Sponsor's protocol ID
- NIASPAN-C05-36
- Status last verified
- Oct 2010
- First submitted
- 5 Oct 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Blanchard V, Ramin-Mangata S, Billon-Crossouard S, Aguesse A, Durand M, Chemello K, Nativel B, Flet L, Chetiveaux M, Jacobi D, Bard JM, Ouguerram K, Lambert G, Krempf M, Croyal M. Kinetics of plasma apolipoprotein E isoforms by LC-MS/MS: a pilot study. J Lipid Res. 2018 May;59(5):892-900. doi: 10.1194/jlr.P083576. Epub 2018 Mar 14.
PubMed 29540575Ferchaud-Roucher V, Croyal M, Moyon T, Zair Y, Krempf M, Ouguerram K. Plasma Lipidome Analysis by Liquid Chromatography-High Resolution Mass Spectrometry and Ion Mobility of Hypertriglyceridemic Patients on Extended-Release Nicotinic Acid: a Pilot Study. Cardiovasc Drugs Ther. 2017 Jun;31(3):269-279. doi: 10.1007/s10557-017-6737-y.
PubMed 28752209
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT01216956
- Acronym / sponsor ID
- NIASPAN-C05-36
- Conditions
- Insulin Sensitivity, Lipoproteins Metabolism, Non Esterified Fatty Acid Kinetics, Lipid Profile
- Keywords
- extended release nicotinic acid, non esterified fatty acid (NEFA), insulin resistance, Cholesteryl ester transfer protein (CETP), High density lipoprotein cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-AlpeUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, GlaxoSmithKline
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Oct 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.
Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the drug has been used for so long, its precise mechanism of action remains elusive. The aim of this study was to characterise the metabolic changes induced by 8 week treatment with Niacin in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. In order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.
Detailed description
24 patients will be included in a double blind placebo controlled cross-over 8 week study comparing placebo to Niaspan (a long release formulation of niacin). In order to prevent any drop out linked to the flushing side effect of niacin, patient will take aspirin (300mg) prior to treatment throughout the study duration. The study will include at start and end of each arm, a full lipoproteins quantification as well as a measure of enzymes involved in lipid metabolism. On day 42 and 56 of each period, after an administration of either placebo or 500mg of immediate release niacin respectively, changes in plasma free fatty acid levels will be measured for 8hours in order to assess potential loss of activity of niacin over time upon chronic treatment with niaspan. Half of the patient will have an exploration of their glucose metabolism using hyperinsulinic clamp technique, whereas in the other half a metabolic turnover study using stable isotopes will focus on their lipoproteins, triglycerides and cholesterol handling. These explorations will be done at the end of each treatment period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended release nicotinic acid | Experimental | Drug: Extended-release nicotinic acid versus placebo |
| Placebo | Placebo comparator | Drug: Extended-release nicotinic acid versus placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Waist circumference > 94cm
- Triglyceride concentration between 150mg/dL and 400mg/dL
- HDL-c < 60mg/dL
- Body mass index: 27 to 35 kg/m²
Key exclusion criteria (5 listed)
- cancer
- diabetes mellitus
- hepatic, renal or digestive disorder
- hypertension
- chronic medical treatment interfering on lipids parameters
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 |
|---|---|---|
| Extended-release nicotinic acid versus placeboVoluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite. | Drug | Extended release nicotinic acid, Placebo |
Primary outcome
Evolution of non-esterified fatty acid and triglycerides concentrations over time
Time frame: After 42 and 56 days of placebo or nicotinic acid treatment
Twelve hours after ingestion of chronic treatment, measures of non esterified fatty acid and triglycerides concentrations were carried out during 480 minutes to assess acute and chronic treatment effect on lipolysis and on triglyceride concentration. To appreciate both acute and chronic effects, subjects received medicinal supplements in addition to their chronic treatment: * On day 42, 500 mg of placebo to assess chronic nicotinic acid effect versus placebo effect * On day 56, 500 mg of immediate-release nicotinic acid (INA) to assess acute versus chronic nicotinic acid effect.
3 secondary outcomes
Insulin sensitivity after treatment
Time frame: After 53 days of placebo or nicotinic acid treatment
Lipoproteins metabolism
Time frame: After 53 days of placebo or nicotinic acid treatment
Lipid profile
Time frame: Before and after placebo or nicotinic acid 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 7 Oct 2010.
- Derived from this study: PubMed 29540575Blanchard V, Ramin-Mangata S, Billon-Crossouard S, Aguesse A, Durand M, Chemello K, Nativel B, Flet L, Chetiveaux M, Jacobi D, Bard JM, Ouguerram K, Lambert G, Krempf M, Croyal M. Kinetics of plasma apolipoprotein E isoforms by LC-MS/MS: a pilot study. J Lipid Res. 2018 May;59(5):892-900. doi: 10.1194/jlr.P083576. Epub 2018 Mar 14.
- Derived from this study: PubMed 28752209Ferchaud-Roucher V, Croyal M, Moyon T, Zair Y, Krempf M, Ouguerram K. Plasma Lipidome Analysis by Liquid Chromatography-High Resolution Mass Spectrometry and Ion Mobility of Hypertriglyceridemic Patients on Extended-Release Nicotinic Acid: a Pilot Study. Cardiovasc Drugs Ther. 2017 Jun;31(3):269-279. doi: 10.1007/s10557-017-6737-y.
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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.
Michel Krempf, PhD, MD principal investigator
Institut National de la Santé Et de la Recheche Médiacle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Insulin Sensitivity and Lipoproteins Metabolism, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe 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 5 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 7 Oct 2010. 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.
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?
Evolution of non-esterified fatty acid and triglycerides concentrations over time (time frame: After 42 and 56 days of placebo or nicotinic acid 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 NCT01216956, 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 7 Oct 2010.