HypothyroidismNCT00770016
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
A study testing Levothyroxin in people with Hypothyroidism, run by University of Aarhus at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- must be of legal age and competent
- Age > 18 years
- presently diagnosed with hypothyroidism
Who cannot join
- alcohol consumption >21 units per week
- Malignant disease
- pregnancy
- magnetic implants or material in the body
- BMI > 30
- Heart disease (NYHA >2)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus,
Aarhus, 8000
About this study
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
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxin
- Keywords
- insulin sensitivity, Substrate metabolism, Fatty liver, intramyocellular lipid, intracellular signaling
- Medical subject headings
- Hypothyroidism, Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxinDrug
Also called Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)
Dosage regulation will follow the local recommendations of treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Levothyroxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracellular lipid content in liver and muscle
Measured: before and after 3 months treatment with growth hormone
intraabdominal lipid content
Measured: before and after treatment
insulin sensitivity
Measured: before and after treatment
substrate metabolism
Measured: before and after treatment
intracellular signaling in the basal state and during insulin stimulation
Measured: before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startJan 2010
- Primary completionJan 2010 (estimated)
- Study completionJan 2011 (estimated)
Why it stopped: no longer interested in doing the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770016
- Sponsor's protocol ID
- LM_HYPO_2008
- Status last verified
- Oct 2010
- First submitted
- 8 Oct 2008
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
- ClinicalTrials.gov ID
- NCT00770016
- Acronym / sponsor ID
- LM_HYPO_2008
- Conditions
- Hypothyroidism
- Keywords
- insulin sensitivity, Substrate metabolism, Fatty liver, intramyocellular lipid, intracellular signaling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no longer interested in doing the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N
- Study start
- Jan 2010
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levothyroxinthe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written informed consent
- must be of legal age and competent
- Age > 18 years
- presently diagnosed with hypothyroidism
Key exclusion criteria (9 listed)
- alcohol consumption >21 units per week
- Malignant disease
- pregnancy
- magnetic implants or material in the body
- BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxinAlso: Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)Dosage regulation will follow the local recommendations of treatment | Drug | 1 |
Primary outcome
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
Results and safety
The study was stopped early (reason given: no longer interested in doing the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
- (Danish Data Protection Agency)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxin in people with Hypothyroidism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no longer interested in doing the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracellular lipid content in liver and muscle (time frame: before and after 3 months treatment with growth hormone). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2010.