- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00522119
Analysis of Genes That Predispose People to Develop High Blood Pressure
Genetic and Functional Analyses of Chromosome 1 Hypertension Susceptibility
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Characteristic Men (n = 460) Women (n = 408) Age (y) 42.2 ± 0.6 45.4 ± 0.7 BMI (kg/m2) 25.6 ± 0.1 27.8 ± 0.3 TCHOL (mg/dL) 202.5 ± 2.1 215.7 ± 2.5 HDL (mg/dL) 52.6 ± 0.6 59.5 ± 0.8 TG (mg/dL) 63.9 ± 1.7 73.8 ± 2.3 SBP (mm Hg) 121.5 ± 0.6 121.4 ± 0.8 DBP (mm Hg) 77.6 ± 0.4 75.8 ± 0.4 Diabetes (%) 0.9 1.0 Current smokers (%) 20.0 0.0
- on lipid-lowering medications 1.1 1.0
- on antihypertensive medications 0.2 0.3
Description
Inclusion criteria:
- Amish individuals from the Lancaster community in PA.
Study-wide Exclusion criteria:
- Age< 20 yrs
- Non-Amish descent
- Currently pregnant or postpartum <6 m
- Blood pressure at the time of screening >180/105 (SBB/DBP) mm Hg
- Prescription medication use potentially affecting outcomes and vitamin or over-the-counter remedies that cannot be willingly or safely discontinued from 1 week before protocol initiation and until the end of the study (ie, β-blockers; calcium channel antagonists; ACE inhibitors; diuretics; lipid-lowering agents; nitrates; systemic glucocorticoids; adrenergic or cholinergic-acting agents, including cold formulas and antidepressants; and diet-weight loss agents)
- Coexisting malignancy
- Serum creatinine>2.0 mg/dL
- AST or ALT >twice the upper limit of normal
- Hematocrit <32%
- TSH <0.4 or >5.5 mIU/L
Intervention-specific exclusion criteria:
- Cold pressor stress test: history of Raynaud's disease
- High-fat challenge: malabsorption disorders, lactose intolerance, symptoms of gallbladder disease, and/or history of pancreatitis
- Dietary salt intervention: stage III or greater congestive heart failure and/or allergies to foods in the diet
- Aspirin intervention: history of bleeding disorder, gastrointestinal bleeding, blood pressure at the time of screening >160/95 mm Hg, current use of aspirin for a condition that would place the subject at increased risk if it were to be discontinued for 14 days before protocol initiation (eg, history of unstable angina, myocardial infarction, angioplasty, coronary artery bypass grafting, atrial fibrillation, stroke or transient ischemic attack, type 2 diabetes, or deep vein thrombosis/other thrombosis), polycythemia (hematocrit >52%), thrombocytosis (platelet count > 500 000), thrombocytopenia (platelet count <75 000), surgery within the last 6 months, aspirin allergy, current breastfeeding, and/or aggregation with collagen 5 μg/mL <6.65 Ω or >26 Ω or no aggregation at baseline with arachidonic acid
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yen Pei C. Chang, PhD, University of Maryland, Baltimore
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1403
- R01HL088120 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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