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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00442624
First received: March 1, 2007
Last updated: March 8, 2012
Last verified: March 2012
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism

Resource links provided by NLM:


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

Biospecimen Retention:   Samples Without DNA

plasma and serum samples


Enrollment: 25
Study Start Date: January 2007
Estimated Study Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442624

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

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00442624     History of Changes
Other Study ID Numbers: EKBB 196/05 SB
Study First Received: March 1, 2007
Last Updated: March 8, 2012
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on November 25, 2014