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A randomized, controlled, open label clinical study on the dynamic changes of leukocyte transcriptome, plasma metabolome and gut microbiota in patients with Graves' disease before and after treatment with methimazole and propylthiouracil

A randomized, controlled, open label clinical study on the dynamic changes of leukocyte transcriptome, plasma metabolome and gut microbiota in patients with Graves' disease before and after treatment with methimazole and propylthiouracil

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047973
Enrollment
Unknown
Registered
2021-06-28
Start date
2021-06-28
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperthyroidism

Interventions

MMI group:Methimazole treatment
PTU group:Propyl thiouracil treatment

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with Graves' disease included newly diagnosed patients and patients with previous history of hyperthyroidism and relapsed more than one year after treatment; 2. The diagnosis of Graves' disease also met the following criteria: (1) Diagnosis of hyperthyroidism; (2) Diffuse goiter of thyroid (confirmed by palpation and B-ultrasound); (3) TRAb positive or exophthalmos and other infiltrative ocular signs or anterior tibial myxedema; 3. Resident in local area, which does not affect follow-up; 4. Aged from 18 to 60 years.

Exclusion criteria

Exclusion criteria: 1. Diabetes mellitus, hypertension, connective tissue disease, adrenal diseases and other chronic diseases need long-term medication; 2. Patients with intestinal diseases such as inflammatory bowel disease, or receiving intestinal surgery; 3. Patients with severe liver, kidney and heart dysfunction; 4. Those who used antithyroid drugs, glucocorticoids and other drugs that may affect the test results in the past year; 5. Those who used antibiotics in recent one month; 6. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Thyroid function;Transcriptome of peripheral blood lymphocyte;Non targeted metabonomics of plasma;Gut microbiota;

Countries

China

Contacts

Public ContactYin Guoshu

The First Affiliated Hospital of Shantou University Medical College

yinguoshu@126.com+86 3417029106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026