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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 o
Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Current Primary Outcome:

  • Change of Serum Adiponectin from baseline [ Time Frame: At baseline and after 12 weeks at follow up ]
    Method: ELISA
  • Change of hsCRP from baseline [ Time Frame: At baseline and after 12 weeks at follow up ]
    Method: ELISA
  • Change in Insulin resistance from baseline by Homeostatic Model Assessment (HOMA-IR) [ Time Frame: At baseline and after 12 weeks at follow up ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum Insulin [ Time Frame: At baseline and after 12 weeks at follow up ]
    Method: ELISA
  • Lipid profile (Total cholesterol) [ Time Frame: At baseline and after 12 weeks at follow up ]
  • Lipid profile (LDL-C) [ Time Frame: At baseline and after 12 weeks at follow up ]
  • Lipid profile (HDL-C) [ Time Frame: At baseline and after 12 weeks at follow up ]
  • Lipid profile (Triglyceride) [ Time Frame: At baseline and after 12 weeks at follow up ]
  • Long term glycemic status by Glycosylated hemoglobin (HbA1c%) [ Time Frame: At baseline and after 12 weeks at follow up ]
  • Change in Insulin resistance from baseline by Quantitative Insulin Sensitivity Check Index (QUICKI) [ Time Frame: At baseline and after 12 weeks at follow up ]
  • Change in Cardiovascular risk assessment scoring (Framingham scoring) from baseline [ Time Frame: At baseline and after 12 weeks at follow up ]


Original Secondary Outcome: Same as current

Information By: All India Institute of Medical Sciences, Bhubaneswar

Dates:
Date Received: June 4, 2015
Date Started: February 1, 2017
Date Completion: February 2019
Last Updated: May 18, 2017
Last Verified: May 2017