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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
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 0
Study Start Date: January 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Levothyroxin
Dosage regulation will follow the local recommendations of treatment
Other Name: Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)

  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

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

No publications provided

Responsible Party: Jens Otto Lunde Jorgensen, Medical Department M, Aarhus University Hospital, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus C
ClinicalTrials.gov Identifier: NCT00770016     History of Changes
Other Study ID Numbers: LM_HYPO_2008
Study First Received: October 8, 2008
Last Updated: October 25, 2010
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

Additional relevant MeSH terms:
Hypothyroidism
Insulin Resistance
Thyroid Diseases
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013