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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Stress and the Nervous System

NCTNCT02339506 (opens ClinicalTrials.gov in a new tab)Other id2014P002423
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
23 participants (actual)
Sponsor
Brigham and Women's Hospital · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Apr 2015
Primary completion
Oct 2016
Completion
Nov 2020
First posted
15 Jan 2015 (estimated)
Last update posted
3 Dec 2025
Conditions
Autonomic Nervous System · Baroreflex · Stress, Physiological

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018201920202021
  1. N/A

    Stress and the Nervous System

    NCT02339506

    Apr 2015 to Nov 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Models of stress such as hypoglycemia have identified that stress results the next day in decreased baroreflex sensitivity. This project will test the hypothesis that these delayed changes in autonomic nervous system function are secondary to a rise in ACTH. The investigators will infuse cosyntropin versus placebo in a double-blind, crossover study in healthy adults and measure the delayed effects on the autonomic system as measured by cardiovagal baroreflex sensitivity.

Interventions

  • CosyntropinDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Cosyntropin

    Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.

  • Placebo comparator

    Normal saline (Placebo)

    Subjects will receive normal saline infusion for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)

    Time frame · Baseline, 4-hours after infusion, 24-hours after infusion

    Registry description

    Cardiovagal baroreflex sensitivity will be measured with the Modified Oxford Technique before, during, and after drug infusions, to evaluate the effects of cosyntropin infusions.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, 4-hours after infusion, 24-hours after infusion

Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)

GroupValue (ms/mmHg)Spread
Cosyntropin17.755.47
Normal Saline (Placebo)16.908.63
Secondary and other outcome results(2)
Other pre specified outcome· 1 day after ACTH

Pain (Quantitative Sensory Testing Using a Thermal Pain Testing Device)

GroupValue
Other pre specified outcomeMean· 1 day after ACTH

Hippocampal Memory (Paired Associative Learning Task)

GroupValue (score on a scale)Spread
Cosyntropin27.83.7
Normal Saline (Placebo)29.32.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo0 / 220 / 222 / 22
Cosyntropin0 / 210 / 210 / 21

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2021

2 results

Effect of adrenocorticotropic hormone infusion on circulating sclerostin levels.

Zaheer et al. 2021Endocrine connectionscited by 3

PMID 34788228PMC8679878DOI 10.1530/ec-21-0263PUB-34788228

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2020

5 results

ACTH Infusion Impairs Baroreflex Sensitivity-Implications for Cardiovascular Hypoglycemia-Associated Autonomic Failure.

Leung et al. 2020The Journal of clinical endocrinology and metabolismcited by 3

PMID 32353115PMC7255850DOI 10.1210/clinem/dgaa221PUB-32353115

Rights unknown5 results
Source linkSee results (5)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • Derivedvan der Boom T, Jia C, Lefrandt JD, Connelly MA, Links TP, Tietge UJF, Dullaart RPF. HDL Cholesterol Efflux Capacity is Impaired in Severe Short-Term Hypothyroidism Despite Increased HDL Cholesterol. J Clin Endocrinol Metab. 2020 Sep 1;105(9):e3355-62. doi: 10.1210/clinem/dgaa411. PMID 32761088

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Subjects must be currently healthy, BMI 18-32 kg/m2, and not be on any medications. This study will recruit men and women. Due to concerns about estrogen's effects on hormone levels and possible contributions of menstrual symptoms on pain sensing thresholds, we will schedule the inpatient studies to avoid the early follicular phase in normally cycling women. Subjects must have normal laboratory values for: 1. Complete blood count 2. Serum creatinine, sodium, potassium, glucose, liver enzymes 3. Urinalysis 4. Urine pregnancy test (if female) 5. Normal ECG Exclusion Criteria: We will exclude individuals with: * Systolic blood pressure \> 140 or \< 90 mm Hg * Diastolic blood pressure \> 90 mm Hg * Creatinine clearance ≤ 60 mL/min, as calculated by MDRD formula * Known DM, CHF, CAD, PVD, CVA, MI, asthma * Known or history of Cushing's disease or adrenal insufficiency * Known neurologic disease * Known psychiatric disease * Steroid use (oral or inhaled, local or systemic injections, within the past 6 months) * Significant concomitant medical illnesses * Current excessive alcohol (\>10oz ethanol/week) * Current use of recreational drugs * Current smokers * Current pregnancy * Chronic use of non-steroidal anti-inflammatory or narcotic medications * Evidence of ischemia or heart block on screening electrocardiogram (greater than type I-second degree heart block, left bundle branch block, or ST-T wave changes in 2 or more contiguous leads) * Subjects taking any prescription medications (other than oral birth control pills) or herbal medications will be excluded.

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