Metabolic Changes in Hypothyroid Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

August 31, 2007

Last Updated Date

February 7, 2008

Start Date ^ICMJE

March 2004

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00524238 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Metabolic Changes in Hypothyroid Patients

Official Title ^ICMJE

Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Open Label, Single Group Assignment

Condition ^ICMJE

Hypothyroidism

Intervention ^ICMJE

Drug: L-thyroxine

Study Arms / Comparison Groups

Other: 11 hypothyroid patients, newly diagnosed, examined before and after treatment
No Intervention: 10 healthy controls

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00524238

Responsible Party

Signe Gjedde, MD, Medical Department M, Aarhus Sygehus

Study ID Numbers ^ICMJE

20030196

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Signe Gjedde, MD

Aarhus University, Clinical Institute

Information Provided By

University of Aarhus

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP