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

NCT00442624 | Completed DMC

• 1 other identifier: EKBB 196/05 SB
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia

Keywords

insomnia; glucose metabolism; insulin resistance

Study Arms (2)

1

Patients with chronic insomnia

2

age, sex, bmi matched healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatient clinic, general population

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and serum samples

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Insulin Resistance

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stefan Bilz, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 2, 2007
• Study Start: January 1, 2007
• Study Completion: December 1, 2008
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

CH (1)