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The Effect of Bariatric Surgery on Thyroid Function and Morphology

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ClinicalTrials.gov Identifier: NCT00871130
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : March 30, 2009
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

Brief Summary:
The aim is to evaluate the effect of dramatic weight loss after bariatric surgery on thyroid function (thyroid hormone levels and particulary morphological changes) in the short and long-term setting of a cross-sectional study. A particular focus will be made with regard to putting into correlation preoperative thyroid function abnormalities and postoperative changes over time with respect to the type of bariatric intervention carried out.

Condition or disease Intervention/treatment
Thyroid Function Obesity Procedure: Bariatric surgery

Detailed Description:

Background:

Over the last decades, there has been an increase in obesity in virtually all population groups with approximately 1.6 billion adults worldwide estimated to be overweight in 2005 and 400 million of these people qualifying as being obese.

Although hormonal disturbances may play a certain role in the development of obesity, more important are the possible consequences of obesity and the influence of surgically-induced rapid weight loss on overall endocrine function of these patients. Studies evaluating the effect of weight loss on thyroid function show inconsistent results. Whilst some authors have shown that weight loss after bariatric surgery may have a positive effect on thyroid dysfunction, especially in individuals with preoperative subclinical hypothyroidism 1 resulting in normalisation of TSH levels, others fail to show any significant postoperative changes.

Objective:

To evaluate the effect of dramatic weight loss after bariatric surgery on thyroid function (thyroid hormone levels and particularly morphological changes) in the short and long-term in the setting of a cross-sectional study. A particular focus will be made with regard to putting into correlation preoperative thyroid function abnormalities and postoperative changes over time with respect to the type of bariatric intervention carried out.

Methods:

BMI, thyroid hormones (TSH, fT3, fT4 levels), need for thyroxin substitution (or equivalent medication) as well as pre- and postoperative morphological changes in the thyroid gland (usually via sonography)and Leptin values will be assessed retrospectively.


Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effect of Bariatric Surgery on Thyroid Function and Morphology, a Retrospective Study
Study Start Date : January 1998
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Bariatric surgery
    gastric banding, gastric bypass or vertical gastroplasty either open or laparoscopic or a combination of any


Primary Outcome Measures :
  1. thyroid hormone levels (change in) [ Time Frame: preoperative, 3, 6 and 12 months postoperative ]

Secondary Outcome Measures :
  1. morphological changes of the thyroid gland [ Time Frame: up to 12 months postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who have received a surgical procedure to result in desired weight reduction (gastric banding, gastric bypass or vertical gastroplasty either open or laparoscopic or a combination of any)
Criteria

Inclusion Criteria:

  • Patients who underwent bariatric surgery between 1998 and 2007

Exclusion Criteria

  • age >18 years

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871130


Locations
Switzerland
Dep.of Visceral and Transplant Surgery, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Vanessa Banz, MD Dep.of Visceral and Transplant Surgery, Bern University Hospital

Publications:
Responsible Party: Vanessa Banz, MD, Department of Visceral and Transplant Surgery, Bern University Hospital
ClinicalTrials.gov Identifier: NCT00871130     History of Changes
Other Study ID Numbers: KEK_13_01_09
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Keywords provided by University Hospital Inselspital, Berne:
Thyroid gland
bariatric surgery
weight loss
thyroid hormones
adult
morbid obesity
cohort

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases