Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism

This study has been terminated.

(no longer interested in doing the study)

Sponsor:

Collaborator:

MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N

Information provided by:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT00770016

First received: October 8, 2008

Last updated: October 25, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 8, 2008
Last Updated Date	October 25, 2010
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 8, 2008)	intracellular lipid content in liver and muscle [ Time Frame: before and after 3 months treatment with growth hormone ] [ Designated as safety issue: No ] intraabdominal lipid content [ Time Frame: before and after treatment ] [ Designated as safety issue: No ] insulin sensitivity [ Time Frame: before and after treatment ] [ Designated as safety issue: No ] substrate metabolism [ Time Frame: before and after treatment ] [ Designated as safety issue: No ] intracellular signaling in the basal state and during insulin stimulation [ Time Frame: before and after treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00770016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
Official Title ^ICMJE	Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
Brief Summary	The aim of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in patients with hypothyroidism
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Hypothyroidism
Intervention ^ICMJE	Drug: Levothyroxin Dosage regulation will follow the local recommendations of treatment Other Name: Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)
Study Arm (s)	Experimental: 1 the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic - intramyocellular lipids in 12 adult patients, recently diagnosed with hypothyroidism Intervention: Drug: Levothyroxin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	0
Estimated Completion Date	January 2011
Estimated Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: written informed consent must be of legal age and competent Age > 18 years presently diagnosed with hypothyroidism Exclusion Criteria: alcohol consumption >21 units per week Malignant disease pregnancy magnetic implants or material in the body BMI > 30 Heart disease (NYHA >2) Uncontrolled hypertension Manifest diabetes mellitus Changes in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00770016
Other Study ID Numbers ^ICMJE	LM_HYPO_2008
Has Data Monitoring Committee	Yes
Responsible Party	Jens Otto Lunde Jorgensen, Medical Department M, Aarhus University Hospital, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus C
Study Sponsor ^ICMJE	University of Aarhus
Collaborators ^ICMJE	MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N
Investigators ^ICMJE	Not Provided
Information Provided By	University of Aarhus
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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