- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00153179
Free Fatty Acids and Vascular Function in Subjects With Diabetes
The Impact of Free Fatty Acid Reduction on Vascular Function and Skeletal Muscle Glucose Utilization in Type 2 Diabetes Mellitus
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
During the past two decades, there has been a steady increase in the incidence of diabetes mellitus, such that nearly 17 million people are now afflicted. The vast majority of these have type 2 diabetes. Over the next 40 years, the type 2 diabetic population in the United States is expected to increase to nearly 30 million.
Diabetes substantially increases the risk of atherosclerosis, and thereby, cardiovascular morbidity and mortality. Indeed, cardiovascular disease causes more than 50% of the mortality in patients with diabetes. People with type 2 diabetes manifest two cardinal signs of dysmetabolism: hyperglycemia and insulin resistance. Insulin resistance is a progressive phenomenon that occurs well before the onset of frank diabetes, and results in alterations in insulin signaling. Experimental studies suggest that insulin signaling is required for vascular homeostasis, and its impairment is associated with endothelial dysfunction. In the clinical setting, insulin resistance is associated with atherosclerosis and predicts cardiovascular events independent of hyperglycemia. Therefore, we will study the importance of insulin signaling in endothelial biology in humans and the effects of free fatty acids on endothelial function in people with type 2 diabetes.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham & Women's Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- type 2 diabetes mellitus (as defined by the National Diabetes Data Group)
- normal cardiovascular exam
- non smoker (for 1 year prior to entry)
- Healthy volunteers
- no known medical problems
- normal cardiovascular exam
- fasting glucose < 110 mg/dL
- non-smoker (for 1 year prior to entry)
Exclusion Criteria:
Type 2 Diabetics
- untreated hypertension (>140/90 mmHg)
- untreated hypercholesterolemia (LDL > 75th percentile for age)
- cigarette smoking within 1 year
- neuropathy requiring medication
- nephropathy (> 300mg/24 hour urinary albumin, or serum creatinine > 1.4 mg/dL
- abnormal cardiovascular exam
- treatment with thiazolidinedione within 1 year
- post-menopausal women taking hormone replacement therapy
(Note: subjects taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) must stop these medications for 2 weeks prior to taking study drug. If blood pressure rises to >140/90, subjects will be prescribed an alternative medication or be withdrawn from the study.
Healthy Volunteers
- abnormal cardiovascular exam
- use of prescription medications
- fasting glucose > 110mg/dL
- cigarette smoking within 1 year
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 1
Acipimox treatment for 7 days
|
subjects will receive acipimox 250 mg orally every 6 hours (or matching placebo) for 7 days, including a dose at 6am on the morning of the study testing visit
Andere Namen:
|
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Placebo-Komparator: 2
placebo treatment for 7 days
|
passendes Placebo
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome
Zeitfenster: 7 days
|
Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images.
Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes.
After 5 minutes, the cuff is rapidly deflated.
This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged).
The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation.
This is flow-mediated dilation.
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7 days
|
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Difference in Insulin-mediated Skeletal Muscle Glucose Utilization Between Test Agent and Placebo
Zeitfenster: baseline, 7 days
|
Insulin sensitivity (M) is measured by using a hyperinsulinaemic-euglycaemic clamp.
Insulin sensitivity (M) was calculated as the average glucose infusion rate (mg/kg of body weight per min) over the last 30 min of the clamp.
Higher values indicate better outcomes (more insulin sensitive), while lower values indicate more insulin resistance.
|
baseline, 7 days
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mark Creager, M.D., Brigham and Women's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2005P-000088
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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