- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00931879
Lovaza® and Microvascular Function in Type 2 Diabetes
The Role of Lovaza® on Microvascular Function and Lipoprotein Profile in Type 2 Diabetes
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
This pilot study is a within-subject repeated measures design. This study will compare the neurophysiological and vascular responses to placebo and treatment with Lovaza® (omega-3-acid ethyl esters, Reliant Pharmaceuticals, Inc.) in subjects with type 2 diabetes, neuropathy, and dyslipidemia.
Lovaza's potential mechanism of action is the inhibition of acyl Coenzyme A:1, 2-diacylglycerol acyltransferase and increased peroxisomal β-oxidation in the liver.
Subjects will be recruited and a baseline of physiological, neurological and hematological profile established for each patient. Forty-four subjects (20 in the active arm, 20 in the placebo arm, and 2 replacements for each arm) will receive 4 g/day Lovaza® tablets or placebo for a period of 6 months. All subjects will receive a physical and neurological exam as well as neurovascular function testing. This includes nerve conduction studies, quantitative sensory testing, quantitative autonomic testing, and skin blood flow testing, which includes, ischemia reperfusion. Lab tests include an insulin resistance profile, hepatic and renal function profiles, lipid profile, C-reactive protein, thyroid stimulating hormone, and fatty acids. Other tests include inflammatory markers such as adiponectin and tumor necrosis factor-α. The study is powered to detect differences in microvascular function after 6 months of Lovaza® and differences in ethnic responses.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 4. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Virginia
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Norfolk, Virginia, Egyesült Államok, 23510
- Strelitz Diabetes Center
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Subjects may be males or non-pregnant, non-lactating females age 18-80 years.
- Subjects must have been diagnosed with type 2 diabetes mellitus according to the current ADA criteria.
- Triglyceride levels above 149 mg/dL
- Minimum of 2 years after diagnosis of type 2 diabetes
- Prior to participation in this study, each subject must sign an informed consent document.
Exclusion Criteria:
- Presence of type 1 diabetes mellitus (defined as C-peptide < 1 ng/ml or diabetes onset at < 35 years of age in a non-obese patient).
- Presence of diabetic retinopathy that is more severe than "background" level.
- Presence of diabetic nephropathy, defined by urine dipstick results greater than 300 mg/100 mL for protein (proteinuria).
- Presence of clinically significant neuropathy that is clearly of non-diabetic origin, e.g. alcoholic or autoimmune.
- Bilateral amputation of lower extremities or foot ulcers involving the great toes. Presence of neuroarthropathy (Charcot deformity) is allowable.
- History of major macrovascular events such as myocardial infarction or stroke.
- Participation in another clinical trial concurrently or within 30 days prior to entry into this study.
- The use of ACE-inhibiting agents or angiotensin receptor blockade therapy (ARB) is allowed but must have been stable for at least 30 days prior to study entry and may not change during the course of the study. This is prudent due to their potential effects on blood flow.
- Patients with moderate or severe hepatic insufficiency or abnormalities of liver function defined as any liver enzymes (aspartate aminotransferase,alanine transaminase, alkaline phosphatase) greater than 3 times the upper limit of normal.
- Presence of pedal edema.
- Presence or history of heart failure New York Heart Association Class II or greater.
- Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study.
- Concomitant use of medications known to exacerbate triglyceride levels, such as estrogens.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Placebo Comparator: Placebo
Subjects are males or non-pregnant, non-lactating females age 18-80 years.
All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL.
Subjects in this arm will be taking placebo for 6 months.
|
Subjects are males or non-pregnant, non-lactating females age 18-80 years.
All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL.
Subjects in this arm will be taking placebo for 6 months.
|
Aktív összehasonlító: omega-3-ethyl esters 4g
Subjects are males or non-pregnant, non-lactating females age 18-80 years.
All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL.
Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
|
Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.
Időkeret: One year
|
19 participants in each arm( placebo or omega-3-ethyl esters 4g) were analyzed .
Conduction velocities and amplitude of the following nerves were compared between each arm: Tibial Nerve Ankle Amplitude, Tibial Nerve Popliteal Amplitude, Median Nerve Wrist Amplitude, Median Nerve Elbow Amplitude, Peroneal Motor Nerve Ankle Amplitude, Peroneal Motor Nerve Below Fibular Amplitude, Peroneal Motor Nerve Above Fibular Amplitude, Sensory Median Nerve Wrist Amplitude, Sensory Ulnar, Sensory Sural Ankle Ampltiude Wrist Ampltiude
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One year
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Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.
Időkeret: One year
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Quantitative Autonomic Function Tests (QAFTs) were performed.
Primarily, power spectral analysis of heart rate variability (HRV) and time- and frequency-domain analyses, including measures of the sympathetic and parasympathetic control of the heart beat (R-R interval), were recorded with deep breathing, Valsalva, and standing from the sitting position maneuvers.
Additionally, the sample difference of the beat to beat (NN) intervals and the TSP was calculated as well as the standard deviation of all normal R-R intervals (sdNN).
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One year
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Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.
Időkeret: One year
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Quantitative Sensory Tests (QSTs), including, cold sensation threshold, cold pain threshold and vibration detection threshold, were used to evaluate peripheral sensory perception.
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One year
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Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds
Időkeret: One year
|
Quantitative Sensory Tests (QSTs), including vibration detection threshold, were used to evaluate peripheral sensory perception.
Mean represents percent change of total group.
Measurements taken at baseline and at one year.
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One year
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Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress.
Időkeret: One year
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Oxidative stress/inflammatory markers (IL1β, IKKβ, TLR4, TNF-α, JNK1, toll-like receptor 2) were assessed through a meal challenge.
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One year
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Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity.
Időkeret: One Year
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One Year
|
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Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency.
Időkeret: One Year
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One Year
|
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Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction
Időkeret: One Year
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One Year
|
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Efficacy Measures Examining Increased Vascular Response to Ischemic Block and to Local Warming at the Dorsum of the Foot.
Időkeret: One Year
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One Year
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Aaron I Vinik, MD, PhD, Eastern Virginia Medical School
- Tanulmányi igazgató: Henri K Parson, PhD, Eastern Virgina Medical School
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- LVZ111903
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az Egyesült Államokban gyártott és onnan exportált termék
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