Stop Atherosclerosis in Native Diabetics Study (SANDS)
2021年6月15日 更新者：Cynthia West
Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes.
This study is a randomized 3-year trial.
The primary endpoint will be a combination of various measures of the carotid artery, (which is an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks and strokes.
The study will also look at secondary endpoints such as how well the heart pumps, fat,protein and inflammatory markers in the blood,and kidney function.
The study enrolled 549 American Indian men and women with diabetes, > 40 years of age and is being conducted in four field centers involving Indian Health Service/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members.
調査の概要
状態
完了
詳細な説明
Diabetes incidence is increasing rapidly in the United States.
Diabetes increases the risk for CVD, the major cause of death in diabetic individuals.
The conventional cardiovascular risk factors of hyperlipidemia and hypertension add to the progression of diabetic vascular disease.
Appropriate treatment targets for LDL-C and blood pressure in diabetic individuals are currently being debated.
The Stop Atherosclerosis in Native Diabetics Study is a randomized, open label, 3-year, clinical trial to examine the effects of aggressive LDL-C (goal < 70 mg/dL) and BP (goal < 115/75 mm Hg) reduction versus the standard goals of < 100 mg/dL for LDL-C and < 130/85 mmHg for BP.
Five hundred forty-nine American Indian men and women > age 40 with type 2 diabetes were randomized to one of two groups.
Lipids and BP are managed using FDA-approved medications in an algorithmic approach.
The presence and progression of atherosclerosis are evaluated by carotid ultrasonography; echocardiography assesses cardiac function.
The primary endpoint is the composite outcome of change in carotid artery intimal medial thickness and fatal/nonfatal cardiovascular events.
These outcomes are combined by using a ranked analysis for carotid thickness and assigning a "worst rank" for a cardiovascular event.
Secondary endpoints include carotid plaque score, left ventricular geometry and function, serum CRP, and safety measures.
Unique aspects of the study design and analysis plan involve changes during the trial of LDL-C treatment goals for participants with baseline or incident CVD in the conventional group, because of changes in the standard of care, and the use of a composite outcome.
Study results will be valuable in understanding the effects of aggressive risk factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in all U.S. populations and will provide evidence for determining optimal LDL-C and BP treatment goals for diabetic patients.
研究の種類
介入
入学 (実際)
548
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Arizona
-
Chinle、Arizona、アメリカ、86503
- Chinle Comprehensive Health Care
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Phoenix、Arizona、アメリカ、85016
- Phoenix Indian Medical Center
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-
Oklahoma
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Lawton、Oklahoma、アメリカ、73507
- USPHS Indian Hospital
-
-
South Dakota
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Rapid City、South Dakota、アメリカ、57701
- Black Hills Center for American Indian Health
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：SANDS Control Group
Standard Treatment for blood pressure and cholesterol
|
|
|
アクティブコンパレータ：SANDS Intervention Group
FDA approved drugs to treat blood pressure and cholesterol
|
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changing LDL Cholesterol
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changing Blood Pressure
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Barbara V Howard, PhD、Medstar Health Research Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2003年5月1日
一次修了 (実際)
2006年11月1日
研究の完了 (実際)
2007年5月1日
試験登録日
最初に提出
2005年9月2日
QC基準を満たした最初の提出物
2005年9月2日
最初の投稿 (見積もり)
2005年9月7日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月7日
QC基準を満たした最後の更新が送信されました
2021年6月15日
最終確認日
2021年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2000-285
- Grant # 1 U01 HL67031 (その他の助成金/資金番号：NHLBI)
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