Metabolic Changes in Hypothyroid Patients

This study has been completed.

Sponsor:

Information provided by:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT00524238

First received: August 31, 2007

Last updated: February 7, 2008

Last verified: February 2008

History of Changes

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: Open Label Primary Purpose: Basic Science
Official Title:	Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Levothyroxine Levothyroxine sodium

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gjedde S, Gormsen LC, Riis AL, Jørgensen JO, Rungby J, Møller 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. Epub 2010 Apr 28.

Responsible Party:	Signe Gjedde, MD, Medical Department M, Aarhus Sygehus
ClinicalTrials.gov Identifier:	NCT00524238 History of Changes
Other Study ID Numbers:	20030196
Study First Received:	August 31, 2007
Last Updated:	February 7, 2008
Health Authority:	Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013

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