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OpenTrials
Completed

NCT Number: NCT02467244

Effect of Levothyroxine on Serum Adiponectin, Insulin Resistance and Cardiovascular Risk in Patients With Hypothyroidism

The aim of this study is to evaluate plasma adiponectin level, insulin resistance, cardiovascular risk and their correlation (if any) in patients with hypothyroidism and also to investigate the effect of levothyroxine on these parameters. The study may explore the lacunae in present treatment protocol and can suggest the possibilities of add-on therapies for a better management.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

About this study

Hypothyroidism is associated with premature atherosclerosis and increased prevalence of coronary artery diseases. Long-term hypothyroidism is associated with severe cardiovascular manifestations including reduced intravascular volume, increased systemic vascular resistance, and hypertension. Hypothyroidism is one of the main causes of secondary dyslipidemia. The classic manifestations of hypothyroidism are raised VLDL, LDL and apo A. The increase in cardiovascular risk is not only due to dyslipidemia, but also to hemodynamic changes, endothelial dysfunction, hormonal and metabolic changes. Insulin resistance and the metabolic syndrome are important cardiovascular risk factors as insulin-resistant individuals with raised TSH have higher LDL concentrations.

Among the various markers associated with obesity and insulin resistance, of particular importance is adiponectin which is inversely related to the degree of adiposity, increases insulin sensitivity, and has antiatherogenic and anti-inflammatory properties, hence may be cardioprotective. Hypoadiponectinaemia is associated with obesity, insulin resistance and type II diabetes, as well as atherosclerosis, hypertension and coronary artery disease.

Treating hypothyroidism with levothyroxine has an antioxidant and cholesterol reducing effect, and thus already has proven beneficial impact on cardiovascular function, blood pressure and lipid profile. But the association of adiponectin and insulin resistance in hypothyroid state and future cardiovascular risk is still not clear because there are few published studies in this domain and result of some the studies are contradictory. The aim of this study is to evaluate plasma adiponectin level, insulin resistance, cardiovascular risk and their correlation (if any) in patients with hypothyroidism and also to investigate the effect of levothyroxine on these parameters.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levothyroxine

Drug

At first visit, after taking detailed history including baseline symptomatology, clinical evaluation, and laboratory investigation, treatment will be started with levothyroxine (50 microgram/day). The dosage of levothyroxine (LT4) will be adjusted (at 4th and 8th week) in an attempt to keep the serum FT4 and TSH concentrations within the normal range. After 12 weeks, all the patients will be followed up, clinical and laboratory tests will be repeated.

Primary outcomes

  1. Change of Serum Adiponectin from baseline

    Time frame: At baseline and after 12 weeks at follow up

    Method: ELISA

  2. Change of hsCRP from baseline

    Time frame: At baseline and after 12 weeks at follow up

    Method: ELISA

  3. Change in Insulin resistance from baseline by Homeostatic Model Assessment (HOMA-IR)

    Time frame: At baseline and after 12 weeks at follow up

Secondary outcomes

  1. Serum Insulin

    Time frame: At baseline and after 12 weeks at follow up

    Method: ELISA

  2. Lipid profile (Total cholesterol)

    Time frame: At baseline and after 12 weeks at follow up

  3. Lipid profile (LDL-C)

    Time frame: At baseline and after 12 weeks at follow up

  4. Lipid profile (HDL-C)

    Time frame: At baseline and after 12 weeks at follow up

  5. Lipid profile (Triglyceride)

    Time frame: At baseline and after 12 weeks at follow up

  6. Long term glycemic status by Glycosylated hemoglobin (HbA1c%)

    Time frame: At baseline and after 12 weeks at follow up

  7. Change in Insulin resistance from baseline by Quantitative Insulin Sensitivity Check Index (QUICKI)

    Time frame: At baseline and after 12 weeks at follow up

  8. Change in Cardiovascular risk assessment scoring (Framingham scoring) from baseline

    Time frame: At baseline and after 12 weeks at follow up

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 10, 2015
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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