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Metabolic Changes in Hypothyroid Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524238
First Posted: September 3, 2007
Last Update Posted: February 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  Purpose

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.


Condition Intervention
Hypothyroidism Drug: L-thyroxine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Enrollment: 22
Study Start Date: March 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
11 hypothyroid patients, newly diagnosed, examined before and after treatment
Drug: L-thyroxine
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.
No Intervention: 2
10 healthy controls

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524238


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Signe Gjedde, MD Aarhus University, Clinical Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Signe Gjedde, MD, Medical Department M, Aarhus Sygehus
ClinicalTrials.gov Identifier: NCT00524238     History of Changes
Other Study ID Numbers: 20030196
First Submitted: August 31, 2007
First Posted: September 3, 2007
Last Update Posted: February 12, 2008
Last Verified: February 2008

Keywords provided by University of Aarhus:
hypothyroidism
glucose turnover
clamp
insulin resistance
lipid turnover
amino acid turnover

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases