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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02467244 |
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Date of registration:
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04/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Levothyroxine on Serum Adiponectin, Insulin Resistance and Cardiovascular Risk in Patients With Hypothyroidism
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Scientific title:
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Effect of Levothyroxine on Serum Adiponectin, Insulin Resistance and Cardiovascular Risk in Patients With Hypothyroidism |
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Date of first enrolment:
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February 1, 2017 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02467244 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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DEBASISH HOTA, MD, DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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AIIMS, Bhubaneswar |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of either sex, aged 18 years or above suffering from hypothyroidism
(hypothyroidism was defined as serum TSH level > 5µIU/ml, serum FT3 level < 1.57
pg/ml, serum FT4 level < 0.7 ng/dL. Subclinical hypothyroidism was defined as an
elevated TSH level and a normal serum FT3 and FT4 level) and need treatment (treatment
is indicated in patients with TSH levels >10 µIU/mL or in patients with TSH levels
between 5 and 10 µIU/mL in conjunction with goiter or positive anti-thyroid peroxidase
antibodies (or both).
- Patients not having hepatic/renal dysfunction, Diabetes mellitus, and chronic
inflammatory diseases and not taking any medications for thyroid disease.
- Euthyroid subjects not having any significant medical disease.
Exclusion Criteria:
- Patients with other comorbidites which can interfere the outcome measures.
- Patients who are already on levothyroxine therapy or taking other medications.
- Patients with subacute thyroiditis were excluded from the study since acute
inflammation could influence the measurements.
- Pregnant and lactating mothers.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypothyroidism
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Intervention(s)
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Drug: Levothyroxine
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Primary Outcome(s)
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Change of hsCRP from baseline
[Time Frame: At baseline and after 12 weeks at follow up]
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Change in Insulin resistance from baseline by Homeostatic Model Assessment (HOMA-IR)
[Time Frame: At baseline and after 12 weeks at follow up]
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Change of Serum Adiponectin from baseline
[Time Frame: At baseline and after 12 weeks at follow up]
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Secondary Outcome(s)
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Lipid profile (HDL-C)
[Time Frame: At baseline and after 12 weeks at follow up]
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Change in Cardiovascular risk assessment scoring (Framingham scoring) from baseline
[Time Frame: At baseline and after 12 weeks at follow up]
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Change in Insulin resistance from baseline by Quantitative Insulin Sensitivity Check Index (QUICKI)
[Time Frame: At baseline and after 12 weeks at follow up]
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Serum Insulin
[Time Frame: At baseline and after 12 weeks at follow up]
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Lipid profile (LDL-C)
[Time Frame: At baseline and after 12 weeks at follow up]
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Lipid profile (Triglyceride)
[Time Frame: At baseline and after 12 weeks at follow up]
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Lipid profile (Total cholesterol)
[Time Frame: At baseline and after 12 weeks at follow up]
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Long term glycemic status by Glycosylated hemoglobin (HbA1c%)
[Time Frame: At baseline and after 12 weeks at follow up]
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Secondary ID(s)
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T/EM-F/Pharm/14/03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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