NCT00770016

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 26, 2010

Status Verified

October 1, 2010

Enrollment Period

Same day

First QC Date

October 8, 2008

Last Update Submit

October 25, 2010

Conditions

Hypothyroidism

Keywords

insulin sensitivitySubstrate metabolismFatty liverintramyocellular lipidintracellular signaling

Outcome Measures

Primary Outcomes (5)

  • intracellular lipid content in liver and muscle

    before and after 3 months treatment with growth hormone

  • intraabdominal lipid content

    before and after treatment

  • insulin sensitivity

    before and after treatment

  • substrate metabolism

    before and after treatment

  • intracellular signaling in the basal state and during insulin stimulation

    before and after treatment

Study Arms (1)

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

Interventions

LevothyroxinDRUG

Dosage regulation will follow the local recommendations of treatment

Also known as: Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • must be of legal age and competent
  • Age \> 18 years
  • presently diagnosed with hypothyroidism

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Links

MeSH Terms

Conditions

HypothyroidismInsulin ResistanceFatty Liver

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

January 1, 2010

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

October 26, 2010

Record last verified: 2010-10

Locations

DK(1)