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

This study is not yet open for participant recruitment.

Verified by University of Aarhus, October 2008

First Received: October 8, 2008 No Changes Posted

Sponsors and Collaborators:	University of Aarhus MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00770016

Purpose

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

Condition	Intervention
Hypothyroidism	Drug: Levothyroxin

Drug Information available for: Thyroxine Levothyroxine Sodium Insulin Levothroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	12
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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	Drug: Levothyroxin Dosage regulation will follow the local recommendations of treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770016

Contacts

Contact: Jens OL Jorgensen	0045 8949 2025	joj@ki.au.dk
Contact: Louise Moller	0045 8949 2019	louisem@dadlnet.dk

Locations

Denmark
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus,
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

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

More Information

Additional Information:

(Central Denmark Region Committee on Biomedical Research Ethics) This link exits the ClinicalTrials.gov site

(Jens Otto Lunde Jorgensen) This link exits the ClinicalTrials.gov site

Louise Møller This link exits the ClinicalTrials.gov site

(Danish Data Protection Agency) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Department M, Aarhus University Hospital, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus C ( Jens Otto Lunde Jorgensen )
Study ID Numbers:	LM_HYPO_2008
Study First Received:	October 8, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00770016 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:

insulin sensitivity
Substrate metabolism
Fatty liver
intramyocellular lipid
intracellular signaling

Study placed in the following topic categories:

Endocrine System Diseases
Hypothyroidism
Fatty Liver

Endocrinopathy
Insulin
Thyroid Diseases

Additional relevant MeSH terms:

Endocrine System Diseases
Hypothyroidism
Thyroid Diseases

ClinicalTrials.gov processed this record on May 06, 2009