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| ID | Type | Description | Link |
|---|---|---|---|
| NIH (INBRE 2-P20-RR016472-09) |
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This study will assess the effect of direct renin inhibition on nerve function in persons with diabetes using a double-blind, placebo-controlled randomized trial involving two treatment arms (i.e., [1] 30 participants enrolled and randomized to 300 mg of Aliskiren; [2] 30 participants enrolled and randomized to placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren | Active Comparator | Pill, 300 mg, once daily, for 6 weeks |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Pill, 300 mg, once daily, for 6 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Before and After Treatment | Systolic blood pressure at baseline and follow-up | baseline and 6 weeks |
| Diastolic Blood Pressure Before and After Treatment | Diastolic blood pressure at baseline and follow-up. | baseline and 6 weeks |
| Serum Renin Level Before and After Treatment | Serum renin level at baseline and follow-up | baseline and 6 weeks |
| Mean Circular Resultant Before and After Treatment | Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable. | baseline and 6 weeks |
| Expiration/Inspiration Ratio Before and After Treatment | Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raelene E Maser, PhD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19713 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren | 300 mg, once daily, for 6 weeks |
| FG001 | Placebo | Once daily, for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren | 300 mg, once daily, for 6 weeks |
| BG001 | Placebo | Once daily, for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure Before and After Treatment | Systolic blood pressure at baseline and follow-up | Posted | Mean | Standard Deviation | mm Hg | baseline and 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aliskiren | 300 mg, once daily, for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raelene E. Maser | University of Delaware/Christiana Care Health System | 302-831-8400 | rmaser@udel.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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| Other |
Placebo orally one tablet once a day for 6 weeks. |
|
| baseline and 6 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Diastolic Blood Pressure Before and After Treatment | Diastolic blood pressure at baseline and follow-up. | Posted | Mean | Standard Deviation | mm Hg | baseline and 6 weeks |
|
|
|
| Primary | Serum Renin Level Before and After Treatment | Serum renin level at baseline and follow-up | Posted | Mean | Standard Deviation | ug/l/h | baseline and 6 weeks |
|
|
|
| Primary | Mean Circular Resultant Before and After Treatment | Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable. | Posted | Mean | Standard Deviation | MCR is unitless | baseline and 6 weeks |
|
|
|
| Primary | Expiration/Inspiration Ratio Before and After Treatment | Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. | Posted | Mean | Standard Deviation | Ratio | baseline and 6 weeks |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Placebo | Once daily, for 6 weeks | 0 | 30 | 3 | 30 |
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