Type 2 Diabetes MellitusPhase 4LOWHDLNCT02153879
Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment
A Phase 4 study testing Fenofibrate and Niacin plus laropiprant in people with Type 2 Diabetes Mellitus and Dyslipidemia, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Dyslipidemia
- What is being tested?
- Fenofibrate and Niacin plus laropiprant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients
- Age from 30 years to 70 years
- HDL not exceeding 50 mg/dl in men or 60 mg/dl in women
Who cannot join
- to be a smoker
- To be diagnosed with diabetes less than three months before
- To have triglyceride levels above 400 mg/dl
- Glycated hemoglobin higher than 9%
- Albuminuria above 300 mg/mg creatinine
- Chronic kidney disease (eFGR <30 ml/min/1.73 m2)
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- Advanced retinopathy
- Neuropathy
- Cardiovascular disease in the last three months
- Chronic liver insufficiency
- Neoplastic disease or any chronic or incapacitating disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative and Quantitative Characterization of HDL in T2D After Fenofibrate or Niacin Treatment in Spanish Population
The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL concentrations.
Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the impact of HDL increasing drugs on HDL qualitative changes.
Read the detailed description
Groups of subjects: a) Diabetic patients with low HDL; b) Non-diabetic patients with low HDL; c) Diabetic patients with normal HDL levels; and d) Non-diabetic patients with normal HDL levels. The studies will be performed after washing out lipid lowering drugs. Intima media thickness (IMT) will be performed in all groups. Main biochemical techniques will be centralised. Isolation and characterisation of HDL subclasses and remnant HDL, as well as a determination and preβ1 HDL will be performed. HDL studies examining HDL proteomic and metabolomic profiles will be performed. Functional studies will determine the effects on the endothelium, inflammation, cholesterol efflux and oxidation according the qualitative changes. These HDL measurements will be repeated in group (a), after they are treated with fibrates or Niacin. HDL metabolism in adipocytes will be extensively studied, and the clinical associations between HDL alterations and plasma AT-derived molecules will be examined.
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemia
- Being tested
- Fenofibrate, Niacin plus laropiprant
- Keywords
- HDL, Niacin, Fenofibrate, Diabetes, Metabolomics
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Also called Secalip
fenofibrate 145/day for 12 weeks
Niacin plus laropiprantDrug
Also called Tredaptive
Niacin 2 g/day plus Laropiprant for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Experimental | Fenofibrate 145 mg/day for 12 weeks Receives: Drug: Fenofibrate |
| Niacin plus Laropiprant | Experimental | Niacin 2g/day plus Laropiprant for 12 weeks Receives: Drug: Niacin plus laropiprant |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L
HDL particles were studied by NMR in T2D patients after treatment with fenofibrate or Niacin
Measured: Two periods of 12 weeks treatment according to crossing over design
Secondary outcomes (1)
Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l)
Apoprotein and antioxidant enzymes composition of HDL were also measured
Measured: Two periods of 12 weeks treatment according to crossing over design
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
- Responsible party
- Principal investigator, LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Luis Masana, Professor, Study director, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153879
- Sponsor's protocol ID
- IISPV-HUSJR-LOWHDL
- Acronym
- LOWHDL
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Characterization of HDL in T2D After Fenofibrate or Niacin Treatment in Spanish Population
- ClinicalTrials.gov ID
- NCT02153879
- Acronym / sponsor ID
- LOWHDL / IISPV-HUSJR-LOWHDL
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemia
- Keywords
- HDL, Niacin, Fenofibrate, Diabetes, Metabolomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jun 2014 (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.
The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL concentrations.
Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the impact of HDL increasing drugs on HDL qualitative changes.
Detailed description
Groups of subjects: a) Diabetic patients with low HDL; b) Non-diabetic patients with low HDL; c) Diabetic patients with normal HDL levels; and d) Non-diabetic patients with normal HDL levels. The studies will be performed after washing out lipid lowering drugs. Intima media thickness (IMT) will be performed in all groups. Main biochemical techniques will be centralised. Isolation and characterisation of HDL subclasses and remnant HDL, as well as a determination and preβ1 HDL will be performed. HDL studies examining HDL proteomic and metabolomic profiles will be performed. Functional studies will determine the effects on the endothelium, inflammation, cholesterol efflux and oxidation according the qualitative changes. These HDL measurements will be repeated in group (a), after they are treated with fibrates or Niacin. HDL metabolism in adipocytes will be extensively studied, and the clinical associations between HDL alterations and plasma AT-derived molecules will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Experimental | Drug: FenofibrateFenofibrate 145 mg/day for 12 weeks |
| Niacin plus Laropiprant | Experimental | Drug: Niacin plus laropiprantNiacin 2g/day plus Laropiprant for 12 weeks |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetic patients
- Age from 30 years to 70 years
- HDL not exceeding 50 mg/dl in men or 60 mg/dl in women
Key exclusion criteria (11 listed)
- to be a smoker
- To be diagnosed with diabetes less than three months before
- To have triglyceride levels above 400 mg/dl
- Glycated hemoglobin higher than 9%
- Albuminuria above 300 mg/mg creatinine
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 |
|---|---|---|
| FenofibrateAlso: Secalipfenofibrate 145/day for 12 weeks | Drug | Fenofibrate |
| Niacin plus laropiprantAlso: TredaptiveNiacin 2 g/day plus Laropiprant for 12 weeks | Drug | Niacin plus Laropiprant |
Primary outcome
HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L
Time frame: Two periods of 12 weeks treatment according to crossing over design
HDL particles were studied by NMR in T2D patients after treatment with fenofibrate or Niacin
1 secondary outcome
Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l)
Time frame: Two periods of 12 weeks treatment according to crossing over design
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 3 Jun 2014.
- Institut Investigacio Sanitaria Pere Virgili- Pere Virgili Health Research instituteLink provided by the sponsor.
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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.
Luis Masana, Professor study director
Institut Investigacio Sanitaria Pere Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenofibrate and Niacin plus laropiprant in people with Type 2 Diabetes Mellitus and Dyslipidemia, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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 3 inclusion and 11 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 3 Jun 2014. 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 Spain. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L (time frame: Two periods of 12 weeks treatment according to crossing over design). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2014.