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Sponsored by: |
University Hospital, Basel, Switzerland |
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Information provided by: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT00442624 |
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.
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism |
plasma and serum samples
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2008 |
Groups/Cohorts |
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Patients with chronic insomnia
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age, sex, bmi matched healthy controls
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
outpatient clinic, general population
Inclusion Criteria:
• Patients with primary chronic insomnia based on clinical history and a polysomnographic study.
Exclusion Criteria:
Contact: Stefan Bilz, MD | +41 61 328 6077 | sbilz@uhbs.ch |
Contact: Eleonora A. Seelig, MD | +41 61 328 6814 | eseelig@uhbs.ch |
Switzerland | |
University Hospital Basel | Recruiting |
Basel, Switzerland, 4031 | |
Contact: Bilz Stefan, MD +41 61 328 6077 sbilz@uhbs.ch |
Principal Investigator: | Stefan Bilz, MD | Division of Endocrinology, University Hospital Basel |
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 |
insomnia glucose metabolism insulin resistance |
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders |
Insulin Resistance Insulin Sleep Disorders, Intrinsic |
Nervous System Diseases |