HypothyroidismNCT00524238
Metabolic Changes in Hypothyroid Patients
A study testing L-thyroxine in people with Hypothyroidism, run by University of Aarhus at 1 site in Denmark.
Trial summary
Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure. This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- L-thyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2004to Aug 2006
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis
- Healthy controls matched regarding sex, age and body mass index
Who cannot join
- Pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover
Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure.
This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients.
- Conditions
- Hypothyroidism
- Being tested
- L-thyroxine
- Keywords
- hypothyroidism, glucose turnover, clamp, insulin resistance, lipid turnover, amino acid turnover
- Medical subject headings
- Hypothyroidism, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-thyroxineDrug
The hypothyroid patients receive usual treatment with L-thyroxine in our out patient clinic. The doctors there subscribe the medication, this study has no protocol regarding this, we observe the patients again after having been biochemically euthyroid for at least two months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 11 hypothyroid patients, newly diagnosed, examined before and after treatment Receives: Drug: L-thyroxine |
| 2 | No intervention | 10 healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startMar 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Signe Gjedde, MD, Principal investigator, Aarhus University, Clinical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524238
- Sponsor's protocol ID
- 20030196
- Status last verified
- Feb 2008
- First submitted
- 31 Aug 2007
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.
PubMed 20427509
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover
- ClinicalTrials.gov ID
- NCT00524238
- Acronym / sponsor ID
- 20030196
- Conditions
- Hypothyroidism
- Keywords
- hypothyroidism, glucose turnover, clamp, insulin resistance, lipid turnover, amino acid turnover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 3 Sep 2007 (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.
Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure.
This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: L-thyroxine11 hypothyroid patients, newly diagnosed, examined before and after treatment |
| 2 | No intervention | –10 healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis
- Healthy controls matched regarding sex, age and body mass index
Key exclusion criteria (1 listed)
- Pregnancy, breastfeeding
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 |
|---|---|---|
| L-thyroxineThe hypothyroid patients receive usual treatment with L-thyroxine in our out patient clinic. The doctors there subscribe the medication, this study has no protocol regarding this, we observe the patients again after having been biochemically euthyroid for at least two months. | Drug | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2008.
- Derived from this study: PubMed 20427509Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.
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Hypothyroidism
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.
Signe Gjedde, MD principal investigator
Aarhus University, Clinical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-thyroxine 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524238, which also lists 1 linked publication.
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 12 Feb 2008.