Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis
1 other identifier
observational
160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 10, 2014
November 1, 2014
2 years
November 5, 2014
November 7, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Single Nucleotide Polymorphisms
2 years
skeletal muscle size of biceps brachii and quadriceps femoris
2 years
Study Arms (2)
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.
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.
Interventions
No interventions will be involved since it is an observational study
Eligibility Criteria
Chinese han population within Sichuan province who is diagnosed with TPP.
You may qualify if:
- A recent history(within three months) of acute limb muscle weakness, hypokalemia and decreased TSH with elevated free FT4, FT3.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
We intend to draw a 3-5mL whole blood from each participant and extract their genome DNA for genetic analysis.
Study Officials
- PRINCIPAL INVESTIGATOR
Haoming Tian, MD.
West China Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 10, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2017
Last Updated
November 10, 2014
Record last verified: 2014-11