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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:
ClinicalTrials.gov Identifier:
NCT00770016
First Posted: October 9, 2008
Last Update Posted: October 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N
Information provided by:
University of Aarhus
  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: None (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:


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 ]
  • intraabdominal lipid content [ Time Frame: before and after treatment ]
  • insulin sensitivity [ Time Frame: before and after treatment ]
  • substrate metabolism [ Time Frame: before and after treatment ]
  • intracellular signaling in the basal state and during insulin stimulation [ Time Frame: before and after treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: October 8, 2008
First Posted: October 9, 2008
Last Update Posted: October 26, 2010
Last Verified: October 2010

Keywords provided by University of Aarhus:
insulin sensitivity
Substrate metabolism
Fatty liver
intramyocellular lipid
intracellular signaling

Additional relevant MeSH terms:
Hypersensitivity
Insulin Resistance
Hypothyroidism
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Thyroid Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs