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

October 25, 2010 updated by: University of Aarhus
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intracellular lipid content in liver and muscle
Time Frame: before and after 3 months treatment with growth hormone
before and after 3 months treatment with growth hormone
intraabdominal lipid content
Time Frame: before and after treatment
before and after treatment
insulin sensitivity
Time Frame: before and after treatment
before and after treatment
substrate metabolism
Time Frame: before and after treatment
before and after treatment
intracellular signaling in the basal state and during insulin stimulation
Time Frame: before and after treatment
before and after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2010

Study Completion (ANTICIPATED)

January 1, 2011

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (ESTIMATE)

October 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2010

Last Update Submitted That Met QC Criteria

October 25, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM_HYPO_2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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