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NCT00770016 Clinical Trial

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

Hypothyroidism Clinical Trial

Official title:
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00770016
Other study ID # LM_HYPO_2008
Secondary ID
Status Terminated
Phase N/A
First received October 8, 2008
Last updated October 25, 2010
Start date January 2010
Est. completion date January 2011

Study information
Verified date October 2010
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date January 2011
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Levothyroxin
Dosage regulation will follow the local recommendations of treatment

Locations
Country Name City State
Denmark Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Aarhus

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary intracellular lipid content in liver and muscle before and after 3 months treatment with growth hormone No
Primary intraabdominal lipid content before and after treatment No
Primary insulin sensitivity before and after treatment No
Primary substrate metabolism before and after treatment No
Primary intracellular signaling in the basal state and during insulin stimulation before and after treatment No
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