Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis

Sponsor
West China Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02287363
Collaborator
(none)
160
36

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Oct 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2016
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Single Nucleotide Polymorphisms [2 years]

  2. skeletal muscle size of biceps brachii and quadriceps femoris [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • West China Hospital

Investigators

  • Principal Investigator: Haoming Tian, MD., West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haoming Tian, professor, West China Hospital
ClinicalTrials.gov Identifier:
NCT02287363
Other Study ID Numbers:
  • HTian
First Posted:
Nov 10, 2014
Last Update Posted:
Nov 10, 2014
Last Verified:
Nov 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2014