Thyroid in Bariatric Surgery
ThyrBar
Changes in Thyroid Function Tests and Texture Following Bariatric Surgery Induced Weight Loss
2 other identifiers
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedMarch 20, 2018
March 1, 2018
2.5 years
February 7, 2017
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
> 3 month or when relevant weight loss has been achieved
Study Arms (2)
Obese patients treated with bariatric surgery
EXPERIMENTALPatients with morbid obesity who were eligible for and willing to have bariatric surgery performed
Obese patients not treated with bariatric surgery
NO INTERVENTIONAge 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
Interventions
patients who had received treatment with bariatric surgery for medical reasons
Eligibility Criteria
You may qualify if:
- Obesity (BMI \> 40 kg/m2)
- Age: 18-65
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 34552538DERIVEDMapurunga 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.
PMID: 33425931DERIVEDBeit 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.
PMID: 31866924DERIVEDKyrou 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.
PMID: 30197625DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 9, 2017
Study Start
June 1, 2011
Primary Completion
December 1, 2013
Study Completion
August 1, 2016
Last Updated
March 20, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share