Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442624
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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 or disease
Chronic Insomnia

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.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism
Study Start Date : January 2007
Study Completion Date : December 2008

Patients with chronic insomnia
age, sex, bmi matched healthy controls

Biospecimen Retention:   Samples Without DNA
plasma and serum samples

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
outpatient clinic, general population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442624

University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Stefan Bilz, MD Cantonal Hospital of St. Gallen

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00442624     History of Changes
Other Study ID Numbers: EKBB 196/05 SB
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders