Metabolic Changes in Hypothyroid Patients - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00524238

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

Drug Information available for: Insulin Levothyroxine Sodium Thyroxine Dextrose Amino acids, branched-chain Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
Official Title:	Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover

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.
2: No Intervention 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

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

Keywords provided by University of Aarhus:

hypothyroidism
glucose turnover
clamp

insulin resistance
lipid turnover
amino acid turnover

Study placed in the following topic categories:

Endocrine System Diseases
Hypothyroidism
Endocrinopathy

Insulin Resistance
Insulin
Thyroid Diseases

ClinicalTrials.gov processed this record on February 09, 2009