Thyrotoxic Periodic ParalysisNCT00443833
Genetic Analysis of Thyrotoxic Periodic Paralysis
An observational study of Thyrotoxic Periodic Paralysis, run by Ramathibodi Hospital.
Trial summary
Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is also seen in individuals having Native American or Hispanic ancestry. Therefore genetic etiology has been hypothesized. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Thyrotoxic Periodic Paralysis
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2005
- Phase
- Observational
- 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 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- TPP
- Hyperthyroid patients from any causes
- Evidence of hypokalemia (k<3.5 mg/dl)from intracellular shift (Urine K<15 mg/dl, TTKG<2)
- Episodic paralysis
Who cannot join
- Hypokalemia from GI or renal loss
About this study
Official title: Genetic Analysis of Thai Patients With Thyrotoxic Periodic Paralysis
Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is also seen in individuals having Native American or Hispanic ancestry. Therefore genetic etiology has been hypothesized. This study, we aim to find the susceptibility genes that associate with TPP. Both candidate genes approach and genome wide association study have been conducted.
Read the detailed description
This study is a genetic association study. It included 50 cases of TPP patients and 80 cases of male, hyperthyroid patients who didn't have hypokalemia as a well characterized controls. After informed consent were obtained, genomic DNA from leukocyte were extracted. Pooled DNA were constructed and whole genome scan using 10K GeneChip microarray were genotyped on pooled genomic DNA.
- Conditions
- Thyrotoxic Periodic Paralysis
- Keywords
- Thyrotoxicosis, genetic association study, periodic paralysis, whole genome scan
- Medical subject headings
- Thyrotoxicosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startJan 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyrotoxic Periodic ParalysisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wallaya Jongjaroenprasert, MD, Principal investigator, Endocrinology Unit, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443833
- Sponsor's protocol ID
- 11-46-21
- Status last verified
- Mar 2007
- First submitted
- 5 Mar 2007
- Last updated
- 6 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Thai Patients With Thyrotoxic Periodic Paralysis
- ClinicalTrials.gov ID
- NCT00443833
- Acronym / sponsor ID
- 11-46-21
- Conditions
- Thyrotoxic Periodic Paralysis
- Keywords
- Thyrotoxicosis, genetic association study, periodic paralysis, whole genome scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2005
- First posted
- 6 Mar 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.
Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is also seen in individuals having Native American or Hispanic ancestry. Therefore genetic etiology has been hypothesized. This study, we aim to find the susceptibility genes that associate with TPP. Both candidate genes approach and genome wide association study have been conducted.
Detailed description
This study is a genetic association study. It included 50 cases of TPP patients and 80 cases of male, hyperthyroid patients who didn't have hypokalemia as a well characterized controls. After informed consent were obtained, genomic DNA from leukocyte were extracted. Pooled DNA were constructed and whole genome scan using 10K GeneChip microarray were genotyped on pooled genomic DNA.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- TPP
- Hyperthyroid patients from any causes
- Evidence of hypokalemia (k<3.5 mg/dl)from intracellular shift (Urine K<15 mg/dl, TTKG<2)
- Episodic paralysis
Key exclusion criteria (1 listed)
- Hypokalemia from GI or renal loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 6 Mar 2007.
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.
Wallaya Jongjaroenprasert, MD principal investigator
Endocrinology Unit, Ramathibodi Hospital, Mahidol University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyrotoxic Periodic Paralysis, run by Ramathibodi Hospital.
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 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 6 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
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 6 Mar 2007.