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Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis

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ClinicalTrials.gov Identifier: NCT02287363
Recruitment Status : Unknown
Verified November 2014 by Haoming Tian, West China Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 10, 2014
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Haoming Tian, West China Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Thyrotoxic Periodic Paralysis Other: No intervention involved

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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis:an Observational Study of Sichuan Individuals in China.
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

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.
Other: No intervention involved
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.
Other: No intervention involved
No interventions will be involved since it is an observational study




Primary Outcome Measures :
  1. Single Nucleotide Polymorphisms [ Time Frame: 2 years ]
  2. skeletal muscle size of biceps brachii and quadriceps femoris [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
We intend to draw a 3-5mL whole blood from each participant and extract their genome DNA for genetic analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese han population within Sichuan province who is diagnosed with TPP.
Criteria

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,


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287363


Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Haoming Tian, MD. West China Hospital

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Responsible Party: Haoming Tian, professor, West China Hospital
ClinicalTrials.gov Identifier: NCT02287363     History of Changes
Other Study ID Numbers: HTian
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms