Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euthyroid group | Fifty (50) age and sex matched euthyroid subjects will serve as the control group. Control euthyroid subjects will be evaluated once at baseline and after 12 weeks. | ||
| Hypothyroid group | Fifty (50) hypothyroid patients attending the outpatient department of General Medicine, AIIMS, Bhubaneswar, will be recruited for the present study following inclusion and exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Serum Adiponectin from baseline | Method: ELISA | At baseline and after 12 weeks at follow up |
| Change of hsCRP from baseline | Method: ELISA | At baseline and after 12 weeks at follow up |
| Change in Insulin resistance from baseline by Homeostatic Model Assessment (HOMA-IR) | At baseline and after 12 weeks at follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Insulin | Method: ELISA | At baseline and after 12 weeks at follow up |
| Lipid profile (Total cholesterol) | At baseline and after 12 weeks at follow up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study will be conducted on 50 patients of hypothyroidism attending the outpatient department of General Medicine, All India Institute of Medical Sciences, Bhubaneswar. Another 50 euthyroid, age-, sex-matched subjects will be recruited as control.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| DEBASISH HOTA, MD, DM | AIIMS, Bhubaneswar | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIIMS, Bhubaneswar | Bhubaneswar | Odisha | 751019 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11172193 | Result | Klein I, Ojamaa K. Thyroid hormone and the cardiovascular system. N Engl J Med. 2001 Feb 15;344(7):501-9. doi: 10.1056/NEJM200102153440707. No abstract available. | |
| 18407156 | Result | Benvenga S, Robbins J. Lipoprotein-thyroid hormone interactions. Trends Endocrinol Metab. 1993 Aug;4(6):194-8. doi: 10.1016/1043-2760(93)90116-v. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lipid profile (LDL-C) | At baseline and after 12 weeks at follow up |
| Lipid profile (HDL-C) | At baseline and after 12 weeks at follow up |
| Lipid profile (Triglyceride) | At baseline and after 12 weeks at follow up |
| Long term glycemic status by Glycosylated hemoglobin (HbA1c%) | At baseline and after 12 weeks at follow up |
| Change in Insulin resistance from baseline by Quantitative Insulin Sensitivity Check Index (QUICKI) | At baseline and after 12 weeks at follow up |
| Change in Cardiovascular risk assessment scoring (Framingham scoring) from baseline | At baseline and after 12 weeks at follow up |
| 14749496 | Result | Fazio S, Palmieri EA, Lombardi G, Biondi B. Effects of thyroid hormone on the cardiovascular system. Recent Prog Horm Res. 2004;59:31-50. doi: 10.1210/rp.59.1.31. |
| 21586104 | Result | Robinson K, Prins J, Venkatesh B. Clinical review: adiponectin biology and its role in inflammation and critical illness. Crit Care. 2011 Apr 20;15(2):221. doi: 10.1186/cc10021. |
| 19682539 | Result | Maury E, Brichard SM. Adipokine dysregulation, adipose tissue inflammation and metabolic syndrome. Mol Cell Endocrinol. 2010 Jan 15;314(1):1-16. doi: 10.1016/j.mce.2009.07.031. Epub 2009 Aug 12. |
| 16984248 | Result | Altinova AE, Toruner FB, Akturk M, Bukan N, Cakir N, Ayvaz G, Arslan M. Adiponectin levels and cardiovascular risk factors in hypothyroidism and hyperthyroidism. Clin Endocrinol (Oxf). 2006 Oct;65(4):530-5. doi: 10.1111/j.1365-2265.2006.02628.x. |
| 21424182 | Result | Kowalska I, Borawski J, Nikolajuk A, Budlewski T, Otziomek E, Gorska M, Straczkowski M. Insulin sensitivity, plasma adiponectin and sICAM-1 concentrations in patients with subclinical hypothyroidism: response to levothyroxine therapy. Endocrine. 2011 Aug;40(1):95-101. doi: 10.1007/s12020-011-9446-5. Epub 2011 Mar 18. |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |