N/A
N=21
Hypoglycemia and the Mineralocorticoid Receptor
Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT01394627 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change From Baseline in Cardiovascular Autonomic Function — -16.00; -16.59 ms/mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Eplerenone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cardiovascular Autonomic Function |
-16.00; -16.59 | — |
| SECONDARY Change From Baseline in Inflammation |
2.03; 2.61 | — |
Summary
The purpose of this study is to look at whether blockade of the mineralocorticoid receptor will result in changes in the cardiovascular and inflammatory response to hypoglycemia.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers
- Males and females age 18 to 40 years
Exclusion Criteria
- Pregnancy
- Lactation
- Menopause
- Any medical condition other than treated hypothyroidism.
- Alcoholism
- Active tobacco use
- In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
- Use of medications other than physiological thyroxine replacement
- Serum potassium >5.0 mmol/L
- Estimated glomerular filtration rate < 60 mL/min
Data sourced from ClinicalTrials.gov (NCT01394627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.