Overview

This trial is active, not recruiting.

Condition thyrotoxic periodic paralysis
Treatment no intervention involved
Sponsor West China Hospital
Start date October 2014
End date October 2016
Trial size 160 participants
Trial identifier NCT02287363, HTian

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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 intervention involved
No interventions will be involved since it is an observational study
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 intervention involved
No interventions will be involved since it is an observational study

Primary Outcomes

Measure
Single Nucleotide Polymorphisms
time frame: 2 years
skeletal muscle size of biceps brachii and quadriceps femoris
time frame: 2 years

Eligibility Criteria

Male participants from 20 years up to 60 years old.

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,

Additional Information

Official title Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis:an Observational Study of Sichuan Individuals in China.
Principal investigator Haoming Tian, MD.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by West China Hospital.