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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Determine the effect of aldosterone on how the body handles glucose (sugar).
Determine the effect of aldosterone on glucose metabolism in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-V/A; LS-V/A | Experimental | High Sodium diet- Vehicle infusion then Aldosterone infusion Low Sodium diet- Vehicle infusion then Aldosterone infusion |
|
| HS-A/V; LS-A/V | Experimental | High Sodium diet- Aldosterone infusion then Vehicle infusion Low Sodium diet- Aldosterone infusion then Vehicle infusion |
|
| LS-V/A; HS-V/A | Experimental | Low Sodium diet- Vehicle infusion then Aldosterone infusion High Sodium diet- Vehicle infusion then Aldosterone infusion |
|
| LS-A/V; HS-A/V | Experimental | Low Sodium diet- Aldosterone infusion then Vehicle infusion High Sodium diet- Aldosterone infusion then Vehicle infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldosterone infusion (A) | Drug | Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion | Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10) | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature. | 3 hours |
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Inclusion Criteria:
Ambulatory subjects, 18 to 70 years of age, inclusive
For female subjects, the following conditions must be met:
a postmenopausal status for at least 1 year, or b status-post surgical sterilization, or c if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day
Metabolic Syndrome as defined by the presence of > 3 of the following:
a Systolic Blood Pressure > 130 mm Hg OR Diastolic Blood Pressure > 85 mm Hg. b Glucose Intolerance (Fasting Plasma Glucose > 100 mg/dL) c Increased triglyceride level > 150mg/dL (1.7mmol/L) d Decreased levels of HDL cholesterol For males, less than 40 mg/dL For females, less than 50 mg/dL e Waist circumference For males, greater than 40 inches (102 cm) For females, greater than 35 inches (89 cm).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Luther, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25173047 | Derived | Ramirez CE, Shuey MM, Milne GL, Gilbert K, Hui N, Yu C, Luther JM, Brown NJ. Arg287Gln variant of EPHX2 and epoxyeicosatrienoic acids are associated with insulin sensitivity in humans. Prostaglandins Other Lipid Mediat. 2014 Oct;113-115:38-44. doi: 10.1016/j.prostaglandins.2014.08.001. Epub 2014 Aug 28. | |
| 25029426 | Derived |
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11 participants did not start the study (5 Participants did Not Meet inclusion or exclusion criteria, 6 declined participation)
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| ID | Title | Description |
|---|---|---|
| FG000 | HS-V/A; LS-V/A | High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone |
| FG001 | HS-A/V; LS-A/V | High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle |
| FG002 | LS-V/A; HS-V/A | Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone |
| FG003 | LS-A/V; HS-A/V | Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Healthy volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | HS-V/A; LS-V/A | High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone |
| BG001 | HS-A/V; LS-A/V | High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Insulin Secretion | Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10) | Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis. | Posted | Mean | Standard Deviation | uU/mL | 3 hours |
|
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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 | Vehicle, HS | Vehicle Infusion, High Salt diet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low potassium | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James M. Luther | Vanderbilt University Medical Center | (615) 936-3420 | James.Luther@Vanderbilt.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| Vehicle Infusion (V) | Drug | Vehicle infusion for 12.5 hours |
|
| High Sodium Diet (HS) | Other | 160 mmol/d sodium diet for 7 days |
|
| Low Sodium Diet (LS) | Other | 20 mmol/d sodium diet for 9 days |
|
| Luther JM, Byrne LM, Yu C, Wang TJ, Brown NJ. Dietary sodium restriction decreases insulin secretion without affecting insulin sensitivity in humans. J Clin Endocrinol Metab. 2014 Oct;99(10):E1895-902. doi: 10.1210/jc.2014-2122. Epub 2014 Jul 16. |
| 24191286 | Derived | Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4. |
| scheduling |
|
| BG002 | LS-V/A; HS-V/A | Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone |
| BG003 | LS-A/V; HS-A/V | Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Glucose (mg/dL) | Mean | Standard Deviation | mg/dL |
|
Aldosterone Infusion, High Salt diet |
| OG003 | Aldosterone, LS | Aldosterone Infusion, Low Salt diet |
|
|
| Secondary | Insulin Sensitivity | Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature. | Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis. | Posted | Mean | Standard Deviation | mg/kg/min per uU/mL*100 | 3 hours |
|
|
|
| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | Vehicle, LS | Vehicle Infusion, Low Salt diet | 0 | 14 | 4 | 14 |
| EG002 | Aldosterone, HS | Aldosterone Infusion, High Salt diet | 0 | 18 | 3 | 18 |
| EG003 | Aldosterone, LS | Aldosterone Infusion, Low Salt diet | 0 | 14 | 4 | 14 |
| IV site discomfort | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lightheadedness | Cardiac disorders | Non-systematic Assessment |
|
| tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Non-systematic Assessment | during study diet, prior to drug infusion |
|
| Nasal congestion or rhinorrhea | General disorders | Non-systematic Assessment |
|
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| D006946 | Hyperinsulinism |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |