NCT01103245
Aldosterone and the Metabolic Syndrome
See it on ClinicalTrials.gov β38 people
50%
50%
19 womenmiddle line = equal numbers19 men
- Phase
- PHASE1
- Paid for by
- Vanderbilt University Medical Center
- Finished
- 2013-09
- Health conditions
- Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders
- Who could join
- Anyone
- Ages
- 18 Years β 70 Years
- Average age
- mean 45.3 years
- Age 65+
- 0%
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- Not reported
Women left out
- No pregnant women
Women who were pregnant could not join.
βPregnancyβ
- No breastfeeding moms
Women who were breastfeeding could not join.
βBreast-feedingβ
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
βif 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.β
- No hormone therapy
Women taking menopause hormones or gender-affirming hormones could not join.
βUse of hormone replacement therapyβ
- Only women past menopause
Women who could still get pregnant were turned away.
βpostmenopausal status for at least 1 year, orβ
- No kidney or liver problems
Women with kidney or liver problems were turned away.
ββ¦ired 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:β
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
βCardiovascular disease such as prior myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure \[Left Ventricular (LV) hypertrophy acceptable\], deep vein thrombosis, pulmonary embolism, second orβ¦β
- No diabetes
Women with diabetes were turned away.
βDiabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or the use of anti-diabetic medicationβ
- No seizures
Women with epilepsy or past seizures were turned away.
βHistory of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attackβ
Study titles and rules are shown in their original English.