Back to resultsMetabolic Changes in Hypothyroid Patients
Primary Purpose
Hypothyroidism
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
L-thyroxine
Sponsored by
About this trial
This is an interventional basic science trial for Hypothyroidism focused on measuring hypothyroidism, glucose turnover, clamp, insulin resistance, lipid turnover, amino acid turnover
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis
- Healthy controls matched regarding sex, age and body mass index
Exclusion Criteria:
- Pregnancy, breastfeeding
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
1
2
Arm Description
11 hypothyroid patients, newly diagnosed, examined before and after treatment
10 healthy controls
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00524238
Brief Title
Metabolic Changes in Hypothyroid Patients
Official Title
Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure.
This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
hypothyroidism, glucose turnover, clamp, insulin resistance, lipid turnover, amino acid turnover
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
11 hypothyroid patients, newly diagnosed, examined before and after treatment
Arm Title
2
Arm Type
No Intervention
Arm Description
10 healthy controls
Intervention Type
Drug
Intervention Name(s)
L-thyroxine
Intervention Description
The hypothyroid patients receive usual treatment with L-thyroxine in our out patient clinic. The doctors there subscribe the medication, this study has no protocol regarding this, we observe the patients again after having been biochemically euthyroid for at least two months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis
Healthy controls matched regarding sex, age and body mass index
Exclusion Criteria:
Pregnancy, breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Gjedde, MD
Organizational Affiliation
Aarhus University, Clinical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20427509
Citation
Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.
Results Reference
derived
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Metabolic Changes in Hypothyroid Patients
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