The Effect of Bariatric Surgery on Thyroid Function and Morphology

March 27, 2009 updated by: University Hospital Inselspital, Berne

The Effect of Bariatric Surgery on Thyroid Function and Morphology, a Retrospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Dep.of Visceral and Transplant Surgery, Bern University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

Inclusion Criteria:

  • Patients who underwent bariatric surgery between 1998 and 2007

Exclusion Criteria

  • age >18 years

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
thyroid hormone levels (change in)
Time Frame: preoperative, 3, 6 and 12 months postoperative
preoperative, 3, 6 and 12 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
morphological changes of the thyroid gland
Time Frame: up to 12 months postoperatively
up to 12 months postoperatively

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Vanessa Banz, MD, Dep.of Visceral and Transplant Surgery, Bern University Hospital

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

January 1, 1998

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

March 30, 2009

Last Update Submitted That Met QC Criteria

March 27, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK_13_01_09

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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