search
Back to results

Thyroid in Bariatric Surgery (ThyrBar)

Primary Purpose

Thyroid, Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bariatric surgery
Sponsored by
University Hospitals Coventry and Warwickshire NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid focused on measuring Bariatric surgery, Leptin, Thyroid function tests

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Obese patients treated with bariatric surgery

    Obese patients not treated with bariatric surgery

    Arm Description

    Patients with morbid obesity who were eligible for and willing to have bariatric surgery performed

    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

    Outcomes

    Primary Outcome Measures

    Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    March 19, 2018
    Sponsor
    University Hospitals Coventry and Warwickshire NHS Trust
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03048708
    Brief Title
    Thyroid in Bariatric Surgery
    Acronym
    ThyrBar
    Official Title
    Changes in Thyroid Function Tests and Texture Following Bariatric Surgery Induced Weight Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospitals Coventry and Warwickshire NHS Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid, Obesity, Insulin Resistance, Autoimmune Thyroiditis
    Keywords
    Bariatric surgery, Leptin, Thyroid function tests

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Obese patients treated with bariatric surgery
    Arm Type
    Experimental
    Arm Description
    Patients with morbid obesity who were eligible for and willing to have bariatric surgery performed
    Arm Title
    Obese patients not treated with bariatric surgery
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Bariatric surgery
    Intervention Description
    patients who had received treatment with bariatric surgery for medical reasons
    Primary Outcome Measure Information:
    Title
    Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery
    Description
    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
    Time Frame
    > 3 month or when relevant weight loss has been achieved

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Obesity (BMI > 40 kg/m2) Age: 18-65 Exclusion Criteria: Diagnosis of obesity secondary to primary endocrine or systemic disease (e.g. Cushing's syndrome) Evidence of clinically relevant thyroid disease Chronic systematic inflammatory disease (e.g. rheumatoid arthritis) Pregnancy Treatment with anti-inflammatory drugs (e.g. corticosteroids) Type 1 diabetes mellitus

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34552538
    Citation
    Ho AHY, Ma SHX, Tan MKB, Bajpai RC. A Randomized Waitlist-Controlled Trial of an Intergenerational Arts and Heritage-Based Intervention in Singapore: Project ARTISAN. Front Psychol. 2021 Sep 6;12:730709. doi: 10.3389/fpsyg.2021.730709. eCollection 2021.
    Results Reference
    derived
    PubMed Identifier
    33425931
    Citation
    Mapurunga MV, Andreoni S, de Oliveira DR, Sarubbi V Jr, Bonilha AC, D'Almeida V, Tomita L, Ramos LR, Demarzo M. Protocol for a Nested Randomized Controlled Trial to Evaluate the Feasibility and Preliminary Efficacy of the Mindfulness Based Health Promotion Program on the Quality of Life of Older Adults Assisted in Primary Care-"The MBHP-Elderly Study". Front Med (Lausanne). 2020 Nov 30;7:563099. doi: 10.3389/fmed.2020.563099. eCollection 2020.
    Results Reference
    derived
    PubMed Identifier
    31866924
    Citation
    Beit Yosef A, Jacobs JM, Shenkar S, Shames J, Schwartz I, Doryon Y, Naveh Y, Khalailh F, Berrous S, Gilboa Y. Activity Performance, Participation, and Quality of Life Among Adults in the Chronic Stage After Acquired Brain Injury-The Feasibility of an Occupation-Based Telerehabilitation Intervention. Front Neurol. 2019 Dec 6;10:1247. doi: 10.3389/fneur.2019.01247. eCollection 2019.
    Results Reference
    derived
    PubMed Identifier
    30197625
    Citation
    Kyrou I, Adesanya O, Hedley N, Wayte S, Grammatopoulos D, Thomas CL, Weedall A, Sivaraman S, Pelluri L, Barber TM, Menon V, Randeva HS, Tedla M, Weickert MO. Improved Thyroid Hypoechogenicity Following Bariatric-Induced Weight Loss in Euthyroid Adults With Severe Obesity-a Pilot Study. Front Endocrinol (Lausanne). 2018 Aug 24;9:488. doi: 10.3389/fendo.2018.00488. eCollection 2018.
    Results Reference
    derived

    Learn more about this trial

    Thyroid in Bariatric Surgery

    We'll reach out to this number within 24 hrs