- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00147251
Stop Atherosclerosis in Native Diabetics Study (SANDS)
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Arizona
-
Chinle, Arizona, Forenede Stater, 86503
- Chinle Comprehensive Health Care
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Indian Medical Center
-
-
Oklahoma
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Lawton, Oklahoma, Forenede Stater, 73507
- USPHS Indian Hospital
-
-
South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Black Hills Center for American Indian Health
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- American Indian men and women 40 years of age or older
- Type 2 DM (according to 1997 ADA criteria and/or previously diagnosed by former ADA or WHO criteria): fasting plasma glucose >= 7.0 mmol/L (126 mg/dL) or 2-hour glucose >= 11.0 mmol/L (>200 mg/dL) after a 75-gram oral glucose tolerance test.
- LDL cholesterol >= 100 mg/dL. within the previous 12 months.
- Systolic BP >= 130 mm Hg. within the previous 12 months.
Exclusion Criteria:
- New York Heart Association Stage III- IV congestive heart failure.
- SBP >180 mmHg (2% of population) or patients with known causes of hypertension.
- History of angioedema.
- Any medical condition that study physicians believe would interfere with study participation or evaluation of results.
- Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
- Serum hepatic transaminase levels 2X the upper limit of normal.
- Participation in any clinical trial of any investigational medication within 3 months prior to this trial.
- Renal insufficiency as indicated by serum creatinine >2.0 for women and >2.4 for men.
- Diagnosis of primary hyperlipidemia in medical record.
- Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible.
- Presence of malignancy or history of any cancer except skin cancer within the past 5 years.
- Pregnancy or lactation. Premenopausal women will be requested to use birth control methods throughout the study and provided educational materials about the risks of using the study medications during pregnancy.
- Unable to obtain quantifiable carotid measure during screening examination.
- Concomitant long term use of cyclosporins (Sandimmune), macrolide antibiotics (erythromycin -many generic and brand name forms, clarithromycin, Biaxin, and Zithromax), azole antifungals (itraconazole-Sporanox, ritonavir, Norvir, and nelfinavir (Viracept).
Orthostatic hypotension as defined by the following:
- The individual has a measured fall of >20 mmHg in systolic BP upon standing associated with symptoms lasting more than one minute (or severe symptoms that would not allow further lowering of BP)
- The standing systolic blood pressure is less than 90 mm.
- Triglyceride level >350 mg/dl.
- Severe aortic stenosis with valve area <=1.0 square cm.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: SANDS Control Group
Standard Treatment for blood pressure and cholesterol
|
|
Aktiv komparator: SANDS Intervention Group
FDA approved drugs to treat blood pressure and cholesterol
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changing LDL Cholesterol
Tidsramme: 36 months
|
LDL cholesterol intervention to lower targets than are currently recommended to retard atherosclerosis measured by LDL-C mg/dL. Scale: LDL cholesterol levels should be less than 100 mg/dL |
36 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changing Blood Pressure
Tidsramme: 36 month follow-up
|
Treatment of blood pressure to prevent/reduce diseases of heart and blood vessels. Measured by mmHG. Normal values should be below 120/80 mm Hg. |
36 month follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Barbara V Howard, PhD, MedStar Health Research Institute
Publikationer og nyttige links
Generelle publikationer
- Roman MJ, Howard BV, Howard WJ, Mete M, Fleg JL, Lee ET, Devereux RB. Differential impacts of blood pressure and lipid lowering on regression of ventricular and arterial mass: the Stop Atherosclerosis in Native Diabetics Trial. Hypertension. 2011 Sep;58(3):367-71. doi: 10.1161/HYPERTENSIONAHA.111.172486. Epub 2011 Jul 25.
- Fleg JL, Mete M, Howard BV, Umans JG, Roman MJ, Ratner RE, Silverman A, Galloway JM, Henderson JA, Weir MR, Wilson C, Stylianou M, Howard WJ. Effect of statins alone versus statins plus ezetimibe on carotid atherosclerosis in type 2 diabetes: the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2198-205. doi: 10.1016/j.jacc.2008.10.031.
- Howard BV, Roman MJ, Devereux RB, Fleg JL, Galloway JM, Henderson JA, Howard WJ, Lee ET, Mete M, Poolaw B, Ratner RE, Russell M, Silverman A, Stylianou M, Umans JG, Wang W, Weir MR, Weissman NJ, Wilson C, Yeh F, Zhu J. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial. JAMA. 2008 Apr 9;299(14):1678-89. doi: 10.1001/jama.299.14.1678.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2000-285
- Grant # 1 U01 HL67031 (Andet bevillings-/finansieringsnummer: NHLBI)
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Kliniske forsøg med Forhøjet blodtryk
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BayerAfsluttet
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Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCAfsluttet
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Centre Chirurgical Marie LannelongueUkendtKronisk trombo-embolisk pulmonal hypertension og pulmonal arteriel hypertensionFrankrig
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University of South FloridaTrukket tilbagePulmonal arteriel hypertension | Familiær primær pulmonal hypertension | Idiopatisk pulmonal arteriel hypertension | Primær pulmonal hypertensionForenede Stater
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Heidelberg UniversityMerck Sharp & Dohme LLCRekrutteringKronisk tromboembolisk pulmonal hypertension | Primær pulmonal arteriel hypertensionTyskland
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertension, essentielForenede Stater
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Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentUkendt