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Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism
This study is currently recruiting participants.
Verified by University Hospital, Basel, Switzerland, October 2007
Sponsored by: University Hospital, Basel, Switzerland
Information provided by: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00442624
  Purpose

We aim to assess the influence of chronic insomnia on the neuroendocrine regulation of the glucose and lipid metabolism to more clearly define the metabolic derangements associated with chronic insomnia and to prove that chronic insomnia is associated with increased levels of stress hormones, cytokines and impaired insulin sensitivity.


Condition Phase
Chronic Insomnia
Phase 0

Drug Information available for: Insulin Dextrose Lipids
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism

Further study details as provided by University Hospital, Basel, Switzerland:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

plasma and serum samples


Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: March 2008
Groups/Cohorts
1
Patients with chronic insomnia
2
age, sex, bmi matched healthy controls

Detailed Description:

Sleep fragmentation has previously been shown to result in activation of the stress axis as indicated by enhanced cortisol and catecholamine release and a proinflammatory state mirrored by increased concentrations of proinflammatory cytokines such as IL-6 and TNFa. Therefore sleep deprivation is associated with a similar pattern of endocrine and proinflammatory alterations that may promote the insulin resistant state. Thus, it is of paramount interest to clearly define the metabolic alterations in patients with primary insomnia.

Patients with with suspected primary insomnia will be recruited from the sleep clinic at the University Hospital Basel and by newspaper ads. Primary insomnia will be diagnosed by a polysomnographic study and the exclusion of secondary causes such as depression, sleep apnea and restless legs syndrome. Eligible patients will be admitted to the CRC for metabolic studies, including baseline blood samples for the measurement of hormones, cytokines and adipokines, a euglycemic-hyperinsulinemic clamp study for the assessment of glucose turnover and insulin sensitivity and in vivo NMR studies to determine intrahepatic and intramyocellular lipid content.

The data obtained in insomnic patients will be compared to those of a control group matched for age, sex, BMI, menopausal status and physical activity selected from the general population.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

outpatient clinic, general population

Criteria

Inclusion Criteria:

• Patients with primary chronic insomnia based on clinical history and a polysomnographic study.

Exclusion Criteria:

  • Diabetes mellitus
  • Known other sleep disorders, such as depression, obstructive sleep apnea and restless legs syndrome
  • Alcohol consumption > 40 g / d in males, > 20 g / d in females, respectively,
  • Patients treated with medications potentially interfering with glucose metabolism, such as systemic steroids, immunosuppressive drugs (cyclosporine, tacrolimus, sirolimus), highly active antiretroviral therapy, hydrochlorothiazide > 25 mg/d
  • Patients treated with lipid lowering drugs such as statins, fibrates, nicotinic acid derivatives, resins and ezetimibe in whom the lipid lowering therapy cannot be safely withheld for the duration of the study.
  • Patients with LDL-cholesterol concentrations > 4.9 mmol/l and fasting triglyceride concentrations > 12 mmol/l.
  • Any significant or unstable hepatic, cardiac, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease.
  • Pregnant or Breast Feeding women
  • Woman of childbearing potential not using a reliable method of birth control such as oral contraceptives or IUD.
  • History of claustrophobia
  • Ferromagnetic implants including pacemakers.
  • Subjects refusing or unable to give written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442624

Contacts
Contact: Stefan Bilz, MD +41 61 328 6077 sbilz@uhbs.ch
Contact: Eleonora A. Seelig, MD +41 61 328 6814 eseelig@uhbs.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Bilz Stefan, MD     +41 61 328 6077     sbilz@uhbs.ch    
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Stefan Bilz, MD Division of Endocrinology, University Hospital Basel
  More Information

Study ID Numbers: EKBB 196/05 SB
Study First Received: March 1, 2007
Last Updated: October 30, 2007
ClinicalTrials.gov Identifier: NCT00442624  
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
insomnia
glucose metabolism
insulin resistance

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Insulin Resistance
Insulin
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009