Sleep and Cytokines During Acute Diverticulitis

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Ismail Gögenür, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01840852
First received: April 13, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to investigate sleep disturbances during Acute uncomplicated diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.


Condition
Acute Diverticulitis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day) [ Time Frame: 1st, 2nd and 30th nights following the admission ] [ Designated as safety issue: No ]
    Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)

  • change in cytokine levels in plasma during the acute uncomplicated diverticulitis from baseline levels at remission [ Time Frame: 1st, 2nd and 30th nights following the admission ] [ Designated as safety issue: No ]
    the Blood sample is taken prior to night sleep; Cytokines are measured by commercial ELISA-kits

  • change in CRP level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission [ Time Frame: 1st, 2nd and 30th nights following the admission ] [ Designated as safety issue: No ]
    the Blood sample is taken prior to night sleep; CRP is measured by standardized conventional method

  • change in leucocyte level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission [ Time Frame: 1st, 2nd and 30th nights following the admission ] [ Designated as safety issue: No ]
    the Blood sample is taken prior to night sleep; Leucocyte is measured by standardized conventional method


Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 13
Study Start Date: April 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute uncomplicated diverticulitis
CT-verified acute uncomplicated diverticulitis managed by antibiotics

Detailed Description:

An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. Sleep is important both in health and disease processes and can affect recovery, morbidity and mortality.

Studies have been done on sleep disturbances after major and minor GI-surgery but never in relation to none surgical inflammatory diseases, namely acute diverticulitis.

This study will investigate sleep architecture by Polysomnography and inflammation by levels of pro inflammatory cytokines in plasma.

Following methods will be applied

Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

Procedure: Plasma cytokines (IL-2, IL-6 and TNF(tumor necrosis factor-alfa)

Procedure: Plasma CRP(C reactive protein) and leukocytes

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75 years managed by antibiotic treatment at Herlev Hospital.

Criteria

Inclusion Criteria:

  • CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
  • Pain and fever occurred less than 72 hours prior to the admission
  • ASA (American Society of Anesthesiologists) score I to III

Exclusion Criteria:

  • Surgical intervention needed
  • Complicated diverticulitis
  • Complications in relation to diverticulitis
  • Pain and fever occurred more than 72 hours prior to the admission
  • In anticoagulant treatment and heart rate control treatment
  • Known Autoimmune disease
  • Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
  • Shift-work or jetlag
  • Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
  • Known psychiatry conditions in treatment with psychopharmaca
  • Daily alcohol intake of more than 5 units or drug abuse
  • Missing written consent
  • Diabetes Mellitus
  • Predicted bad compliance
  • Pregnant or breast-feeding
  • Urine or fecal incontinence
  • Severe kidney disease
  • Current cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840852

Locations
Denmark
Department D, Herlev Hospital
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Lundbeck Foundation
Investigators
Principal Investigator: Ismail Gögenur, M.D. University of Copenhagen, Herlev Hospital
  More Information

No publications provided

Responsible Party: Ismail Gögenür, Senior resident and D.Sc., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01840852     History of Changes
Other Study ID Numbers: CHU-1
Study First Received: April 13, 2013
Last Updated: February 24, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014