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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01103245 |
Purpose
The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.
| Condition | Intervention |
|---|---|
|
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |
Drug: Renin-Angiotensin-Aldosterone System (RAAS) Activation Drug: Administration of Aliskiren, Spironolactone, or Placebo Drug: Increased Dose, Combination, or Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Aldosterone and the Metabolic Syndrome: Renin Inhibition Versus Mineralocorticoid Receptor (MR) Antagonism |
| Estimated Enrollment: | 168 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Renin-Angiotensin Aldosterone Activation
Renin-Angiotensin-Aldosterone System (RAAS) Activation
|
Drug: Renin-Angiotensin-Aldosterone System (RAAS) Activation
Subjects will be receive a dose of Hydrochlorothiazide (HCTZ) for 12 weeks and be given a calculated diet during the last 5 days of this period. Serum potassium levels, urine samples, and blood levels of insulin secretion will be measured.
Other Name: HCTZ, Professional Compounding Centers of America (PCCA)
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Active Comparator: Aliskiren, Spironolactone, or Placebo
Determination of effects of MR antagonism or renin inhibition.
|
Drug: Administration of Aliskiren, Spironolactone, or Placebo
Subjects will be receive a dose of Aliskiren, Spironolactone, or placebo for 4 weeks and be given a calculated diet during the last 5 days of this period. Serum potassium levels, urine samples, and blood levels of insulin secretion will be measured.
Other Names:
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Active Comparator: Increased Dose, Combination, or Placebo
Determination of effects of MR antagonism and/or renin inhibition.
|
Drug: Increased Dose, Combination, or Placebo
Subjects will be receive either an increased dose of the present medication (Aliskiren or Spironolactone) or a combination of the two or a placebo for 4 weeks and be given a calculated diet during the last 5 days of this period. Serum potassium levels, urine samples, and blood levels of insulin secretion will be measured.
Other Names:
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The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on fasting blood glucose and glucose-stimulated insulin secretion in humans.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects meeting all of the following conditions will be included in the study:
For female subjects, the following conditions must be met:
Metabolic Syndrome as defined by the presence of > 3 of the following:
Decreased levels of High-Density Lipoprotein (HDL) cholesterol
Waist circumference
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Impaired renal function [estimated glomerular filtration rate (eGFR) of <60ml/min] as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dl and age in years:
eGFR (ml/min/1.73m2)=175 • Scr-1.154 • age-0.203 • (1.212 if black) • (0.742 if female)
Contacts and Locations| Contact: Loretta Byrne, RN | 615-322-2105 | loretta.byrne@vanderbilt.edu |
| Contact: James Luther, MD | 615-343-8701 | james.luther@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Loretta Byrne, RN 615-322-2105 loretta.byrne@vanderbilt.edu | |
| Principal Investigator: James M Luther, MD | |
| Sub-Investigator: Maneesh C. Kanal, BA | |
| Principal Investigator: | James M Luther, MD | Vanderbilt University |
More Information
| Responsible Party: | James M. Luther, MD, MSCI, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01103245 History of Changes |
| Other Study ID Numbers: | 091072, 09CRP2261428 |
| Study First Received: | April 12, 2010 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Glucose Insulin |
|
Diabetes Mellitus Endocrine System Diseases Metabolic Diseases Metabolic Syndrome X Glucose Metabolism Disorders Insulin Resistance Hyperinsulinism Mineralocorticoids Spironolactone Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Aldosterone Antagonists Hormone Antagonists Diuretics Natriuretic Agents Cardiovascular Agents Therapeutic Uses |