Evidence map›Paper›PMID 29659888›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2018

Randomized, Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Metabolic and Inflammatory Indices in HIV.

Suman Srinivasa, Kathleen V Fitch, Kimberly Wong, Timothy K O'Malley, Patrick Maehler, Karen L Branch, Sara E Looby, Tricia H Burdo, Edgar L Martinez-Salazar, Martin Torriani and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04153136 (Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04153136 phase2completednot on this mapstarted 2020, after this paper: background citation

Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study

TypeinterventionalSponsorMassachusetts General HospitalRan2020 to 2025Enrolled39ConditionsHIV/AIDS, Heart Failure With Preserved Ejection FractionArmsSacubitril-Valsartan 49-51Mg Oral Tablet, Placebo oral tablet
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Adjunct Therapy for CD4Frontiers in immunology · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Heart Failure in Type 2 Diabetes Mellitus.Circulation research · 2019
    Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 1 country.

Suman SrinivasaProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Kathleen V FitchProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Kimberly WongProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Timothy K O'MalleyProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Patrick MaehlerProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Karen L BranchProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Sara E LoobyProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Tricia H BurdoDepartment of Neuroscience, Temple University School of Medicine, Philadelphia, Pennsylvania.
Edgar L Martinez-SalazarDivision of Musculoskeletal Imaging and Intervention, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Martin TorrianiDivision of Musculoskeletal Imaging and Intervention, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Shannon H LyonsDivision of Cardiovascular Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Julian WeissProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Meghan FeldpauschProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Takara L StanleyProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Gail K AdlerDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Steven K GrinspoonProgram in Nutritional Metabolism, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Massachusetts General Hospital · USHarvard University · USBrigham and Women's Hospital · USTemple University · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Takara Leah Stanley · 1994 to 2026
$31.6M
Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
TESTOSTERONE AND GROWTH HORMONE EFFECTS IN AIDS WASTINGR01DK049302 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI ADLER, GAIL KURR, GRINSPOON, STEVEN K. · 1995 to 2020
$12.2M
TRAINING PROGRAM IN HYPERTENSIONT32HL007609 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI ADLER, GAIL KURR · 1985 to 2022
$10.2M
Aldosterone and Diabetic Cardiovascular Disease: Research and Mentoring ProgamK24HL103845 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI ADLER, GAIL KURR · 2011 to 2021
$1.6M
Physiologic Investigation of the Renin-Angiotensin-Aldosterone System to Understand Arterial Inflammation in HIVK23HL136262 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI SRINIVASA, SUMAN · 2017 to 2021
$960k
NCATS NIH HHS UL1 TR000170NCATS NIH HHS UL1 TR001102NCRR NIH HHS UL1 RR025758NHLBI NIH HHS K23 HL136262NHLBI NIH HHS K24 HL103845NHLBI NIH HHS T32 HL007609NIDDK NIH HHS P30 DK040561NIDDK NIH HHS R01 DK049302
6 · The paper itself

Abstract

Context: HIV-infected individuals demonstrate increased renin-angiotensin-aldosterone system activation in association with visceral adiposity, insulin resistance, and inflammation. A physiologically based treatment approach targeting mineralocorticoid receptor (MR) blockade may improve metabolic and inflammatory indices in HIV. Objective: To investigate effects of eplerenone on insulin sensitivity, inflammatory indices, and other metabolic parameters in HIV. Design: Six-month, double-blind, randomized, placebo-controlled trial. Setting: Academic clinical research center. Participants: HIV-infected individuals with increased waist circumference and abnormal glucose homeostasis. Intervention: Eplerenone 50 mg or placebo daily. Outcome: The primary end point was change in insulin sensitivity measured by the euglycemic-hyperinsulinemic clamp technique. Secondary end points included change in body composition and inflammatory markers. Results: Forty-six individuals were randomized to eplerenone (n = 25) vs placebo (n = 21). Eplerenone did not improve insulin sensitivity [0.48 (-1.28 to 1.48) vs 0.43 (-1.95 to 2.55) mg/min/μIU/mL insulin; P = 0.71, eplerenone vs placebo] when measured by the gold standard euglycemic-hyperinsulinemic clamp technique. Intramyocellular lipids (P = 0.04), monocyte chemoattractant protein-1 (P = 0.04), and high-density lipoprotein (P = 0.04) improved among those randomized to eplerenone vs placebo. Trends toward decreases in interleukin-6 (P = 0.10) and high-sensitivity C-reactive protein (P = 0.10) were also seen with eplerenone vs placebo. Plasma renin activity and aldosterone levels increased in the eplerenone vs placebo-treated group, demonstrating expected physiology. MR antagonism with eplerenone was well tolerated among the HIV population, with no considerable changes in blood pressure or potassium. Conclusion: MR blockade may improve selected metabolic and inflammatory indices in HIV-infected individuals. Further studies are necessary to understand the clinical potential of MR antagonism in HIV.

Indexed as

AdiposityAdultAgedBlood PressureDouble-Blind MethodEplerenoneFemaleGlucose Clamp TechniqueHIV InfectionsHumansInflammationInsulin ResistanceLipidsMaleMiddle AgedMineralocorticoid Receptor AntagonistsEplerenoneLipidsMineralocorticoid Receptor Antagonists

Identifiers

PMID29659888
PMCPMC6370281
OpenAlexW2795416835

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.