Stop Atherosclerosis in Native Diabetics Study

NCT00147251 | Completed Phase 4 Results DMC

• 2 other identifiers: 2000-285Grant # 1 U01 HL67031
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Cardiovascular Disease; Hypertension; Hyperlipidemia; Diabetes; Carotid Atherosclerosis

Keywords

lowering LDL and BP below current targets; LDL cholesterol treatment; blood pressure treatment; carotid intimal medial thickness; prevent progression of CVD

Outcome Measures

Primary Outcomes (1)

• Changing LDL Cholesterol

  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

Secondary Outcomes (1)

• Changing Blood Pressure

  36 month follow-up

Study Arms (2)

SANDS Control Group

NO INTERVENTION

Standard Treatment for blood pressure and cholesterol

SANDS Intervention Group

ACTIVE COMPARATOR

FDA approved drugs to treat blood pressure and cholesterol

Drug: FDA approved drugs to treat blood pressure and cholesterol

Interventions

FDA approved drugs to treat blood pressure and cholesterol DRUG

Also known as: No Intervention

SANDS Intervention Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Cynthia West: lead

Study Sites (4)

Chinle Comprehensive Health Care

Chinle, Arizona, 86503, United States

Location

Phoenix Indian Medical Center

Phoenix, Arizona, 85016, United States

Location

USPHS Indian Hospital

Lawton, Oklahoma, 73507, United States

Location

Black Hills Center for American Indian Health

Rapid City, South Dakota, 57701, United States

Location

Related Publications (3)

• 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.

  PMID: 21788602 DERIVED

• 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.

  PMID: 19095139 DERIVED

• 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.

  PMID: 18398080 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Hyperlipidemias; Diabetes Mellitus; Carotid Artery Diseases

Interventions

Cholesterol

Condition Hierarchy (Ancestors)

Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Barbara V Howard
• Organization: MedStar Research Institute

barbara.v.howard@medstar.net

301-560-7305

Study Officials

• Barbara V Howard, PhD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phoenix Field Office Manager

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: May 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: May 1, 2007
• Last Updated: July 7, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-06

Locations

US (4)