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

NCT02467244 | Completed

• 1 other identifier: T/EM-F/Pharm/14/03
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Keywords

Hypothyroidism; Serum adiponectin; hsCRP; Homeostatic Model Assessment (HOMA-IR); Quantitative Insulin Sensitivity Check Index (QUICKI); Cardiovascular risk assessment scoring (Framingham scoring); Levothyroxin

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Serum Insulin

  At baseline and after 12 weeks at follow up

• Lipid profile (Total cholesterol)

  At baseline and after 12 weeks at follow up

• 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

Study Arms (2)

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.

Drug: Levothyroxine

Interventions

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.

Hypothyroid group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS, Bhubaneswar

Bhubaneshwar, Odisha, 751019, India

Location

Related Publications (7)

• 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.

  PMID: 11172193 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.

  PMID: 18407156 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.

  PMID: 14749496 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.

  PMID: 21586104 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.

  PMID: 19682539 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.

  PMID: 16984248 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.

  PMID: 21424182 RESULT

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• DEBASISH HOTA, MD, DM

  AIIMS, Bhubaneswar

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 10, 2015
• Study Start: February 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

IN (1)