Status:
COMPLETED
Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-65 years
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 insomn...
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 c...
Eligibility Criteria
Inclusion
- • Patients with primary chronic insomnia based on clinical history and a polysomnographic study.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00442624
Start Date
January 1 2007
End Date
December 1 2008
Last Update
March 9 2012
Active Locations (1)
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1
University Hospital Basel
Basel, Basel, Switzerland, 4031