- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02287363
Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis
November 7, 2014 updated by: Haoming Tian, West China Hospital
Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis:an Observational Study of Sichuan Individuals in China.
The study aims to analyze the genetic variance between thyrotoxic periodic paralysis (TPP) patients and pure hyperthyroidism individuals.
Meanwhile, the investigators also intended to evaluate the morphological difference in effected skeletal muscles and investigate their relation with genetic variance.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Chinese males of their third and forth decades are extremely predisposed to periodic paralysis when they are hyperthyroid.
Due to their imbalanced predilection to the disease, genetic variance is considered to be critical to the pathogenesis.
In addition, since proximal limb skeletal muscles are the major sites of target, and they are also believed to play a role in the disease generation.
Thus, we intend to analyze the genetic and morphological variances between TPP patients and pure hyperthyroidism patients and simultaneously the relation between genetic variance and morphological difference.
In this way, we hope to provide evidence for a better understanding of the disease.
Study Type
Observational
Enrollment (Anticipated)
160
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Chinese han population within Sichuan province who is diagnosed with TPP.
Description
Inclusion Criteria:
A recent history(within three months) of acute limb muscle weakness, hypokalemia and decreased TSH with elevated free FT4, FT3.
Exclusion Criteria:
Hyperthyroid myopathy with long term muscle weakness, family periodic paralysis, renal tubular acidosis, hyperaldosteronism, hemiplegia, paraplegia, or any history of other metabolic or traumatic muscular disease,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TPP group
TPP patients(between episodes of paralysis), the inclusion criteria consisted of a certain history of acute limb muscle weakness, hypokalemia and decreased TSH with elevated free FT4, FT3.
Subjects who suffered from hyperthyroid myopathy with long term muscle weakness, family periodic paralysis, renal tubular acidosis, hyperaldosteronism, hemiplegia, paraplegia, or any history of other metabolic or traumatic muscular disease were excluded.
|
No interventions will be involved since it is an observational study
|
hyperthyroidism group
Control group, we included subjects with evidence of aberrant thyroid function (decreased TSH, elevated FT4, FT3) without paralysis.
Graves' disease(GD) was preferred which required information concerning either increased thyrotrophin receptor antibody(TRAb) level, ophthalmopathy or diffusively enlarged goiter.
Individuals with pure thyroid associated ophthalmopathy, history of thyroidectomy due to malignancy or adenoma as well as subacute thyroiditis and pituitary hyperthyroidism were excluded.
|
No interventions will be involved since it is an observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Single Nucleotide Polymorphisms
Time Frame: 2 years
|
2 years
|
skeletal muscle size of biceps brachii and quadriceps femoris
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Haoming Tian, MD., West China Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
November 5, 2014
First Submitted That Met QC Criteria
November 7, 2014
First Posted (Estimate)
November 10, 2014
Study Record Updates
Last Update Posted (Estimate)
November 10, 2014
Last Update Submitted That Met QC Criteria
November 7, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTian
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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