Status:
UNKNOWN
Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP
Lead Sponsor:
King Saud University
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at ...
Detailed Description
Research Problem: Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyro...
Eligibility Criteria
Inclusion
- Patients \>18 years old
- With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range
- With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled.
- With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization.
Exclusion
- Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization.
- Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c \>9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons.
- Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter.
- State of pregnancy, Breast feeding or allergy to levothyroxine.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01486667
Start Date
October 1 2011
Last Update
December 8 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Sleep Disorders Center
Riyadh, Riyadh Region, Saudi Arabia, 11472