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

Primary Purpose

Hypothyroidism

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Levothyroxin
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypothyroidism focused on measuring insulin sensitivity, Substrate metabolism, Fatty liver, intramyocellular lipid, intracellular signaling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

intracellular lipid content in liver and muscle
intraabdominal lipid content
insulin sensitivity
substrate metabolism
intracellular signaling in the basal state and during insulin stimulation

Secondary Outcome Measures

Full Information

First Posted
October 8, 2008
Last Updated
October 25, 2010
Sponsor
University of Aarhus
Collaborators
MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N
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1. Study Identification

Unique Protocol Identification Number
NCT00770016
Brief Title
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
Official Title
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
no longer interested in doing the study
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
insulin sensitivity, Substrate metabolism, Fatty liver, intramyocellular lipid, intracellular signaling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Levothyroxin
Other Intervention Name(s)
Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)
Intervention Description
Dosage regulation will follow the local recommendations of treatment
Primary Outcome Measure Information:
Title
intracellular lipid content in liver and muscle
Time Frame
before and after 3 months treatment with growth hormone
Title
intraabdominal lipid content
Time Frame
before and after treatment
Title
insulin sensitivity
Time Frame
before and after treatment
Title
substrate metabolism
Time Frame
before and after treatment
Title
intracellular signaling in the basal state and during insulin stimulation
Time Frame
before and after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus,
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://person.au.dk/da/joj@afdm.au.dk/act
Description
(Jens Otto Lunde Jorgensen)
URL
http://person.au.dk/da/louisem@dadlnet.dk/
Description
Louise Møller
URL
http://www.datatilsynet.dk/english/
Description
(Danish Data Protection Agency)

Learn more about this trial

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

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