Thyroid in Bariatric Surgery (ThyrBar)

March 19, 2018 updated by: Martin Weickert, University Hospitals Coventry and Warwickshire NHS Trust

Changes in Thyroid Function Tests and Texture Following Bariatric Surgery Induced Weight Loss

This study is expected to provide novel data regarding potential structural and functional changes of the thyroid gland in morbidly obese adults following significant weight loss through bariatric surgery. These data will complement evidence from epidemiological studies regarding the association of obesity and alterations in thyroid function. Potentially this study may justify further longer-term studies regarding the effects of weight gain and/or weight loss on the morphology of the thyroid gland and could help to form recommendations regarding follow-up investigations for the thyroid in morbidly obese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alterations in thyroid function are reported in obesity. Thyroid hormones and thyroid-stimulating hormone (TSH) concentrations have been variously described as normal, elevated, or low in morbidly obese patients compared with normal weight controls. However, it is a common observation that a significant proportion of patients with morbid obesity display slightly increased serum levels of TSH, while even relatively mild elevations of serum TSH are associated with an increase in the occurrence of obesity. Of note, abnormalities in thyroid function and TSH mostly normalize after weight loss, suggesting that these biochemical alterations are reversible. Despite uncertainty regarding the underlying mechanisms, it has been suggested that neither autoimmunity nor iodine deficiency seems to play a critical role. Several alternative mechanisms leading to hyperthyrotropinemia have been hypothesized, which include impaired feedback due to decreased number of triiodothyronine (T3) receptors in the hypothalamus, and variations in peripheral deiodinase activity. Leptin, in addition to regulating body weight and satiation, has also been shown to mediate the production of pro-TRH in cultured fetal rat hypothalamic neurons. Partial regulation of TSH by leptin has been also reported in humans. In addition, peripheral thyroid hormone metabolism appears to be reflected by the ratio of T3 to reverse T3 (rT3) (T3/rT3-ratio). We have shown that the T3/rT3-ratio is significantly increased in insulin resistant patients compared to their insulin sensitive partners despite comparable TSH values. Given that obesity is strongly associated with insulin resistance, and thyroid hormones are known to modulate carbohydrate metabolism, e.g. by affecting cellular glucose uptake, possible changes in the T3/fT3 ratio following weight loss after bariatric surgery could be of interest.

Data from cross-sectional studies further indicate that the thyroid structure of obese patients can be also affected, independent of the existence of autoimmune thyroiditis as indicated by the presence of auto-antibodies such as TPO. Ultrasound (US) scans are able to accurately characterize the echographic structure of thyroid tissue, in addition to estimation of thyroid volume and identification of non-palpable thyroid nodules. The typical normal thyroid parenchyma has a distinct high echo density due to the follicle structure, which contrasts well with tissue of the collar muscles. The interface between thyroid cells and the colloid exhibits elevated acoustic impedance, causing high-frequency acoustic waves to be reflected back to the US probe. However, in autoimmune thyroid diseases both lymphocytic infiltration and disruption of normal tissue architecture cause a reduction in thyroid echogenicity, whereas other tissues close by such as muscle tissue appear to remain unaffected. Only few previous studies reported on the morphology of the thyroid gland in adults with morbid obesity. Given that thyroid function has been reported to return to normal after weight loss, research questions are also raised about the potential reversibility of thyroid structural abnormalities following substantial weight loss in previously morbidly obese patients.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Obesity (BMI > 40 kg/m2)
  2. Age: 18-65

Exclusion Criteria:

  1. Diagnosis of obesity secondary to primary endocrine or systemic disease (e.g. Cushing's syndrome)
  2. Evidence of clinically relevant thyroid disease
  3. Chronic systematic inflammatory disease (e.g. rheumatoid arthritis)
  4. Pregnancy
  5. Treatment with anti-inflammatory drugs (e.g. corticosteroids)
  6. Type 1 diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese patients treated with bariatric surgery
Patients with morbid obesity who were eligible for and willing to have bariatric surgery performed
Procedure: Bariatric surgery
patients who had received treatment with bariatric surgery for medical reasons
No Intervention: Obese patients not treated with bariatric surgery
Age and BMI matched patients with morbid obesity who either were not eligible for or were not willing to have bariatric surgery performed - no sufficient number of matched patients has completed the study; the arm of obese patients not treated with bariatric surgery has been discarded for the purpose of the analyses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery
Time Frame: > 3 month or when relevant weight loss has been achieved
Measurement of thyroid ultrasound (grey scale assessment, volume, echogenicity) and thyroid function tests (free T4, free T3, TSH and rT3) at baseline and at least 3 months after surgery when relevant weight loss is achieved
> 3 month or when relevant weight loss has been achieved

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/WM/0085
  • ID74554 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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