The Effect of Bariatric Surgery on Thyroid Function and Morphology

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871130
• Other study ID #: KEK_13_01_09
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: March 27, 2009
• Start date: January 1998
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent bariatric surgery between 1998 and 2007

Exclusion Criteria

• age >18 years

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obesity
• Thyroid Diseases
• Thyroid Function

Intervention

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

Locations

Country	Name	City	State
Switzerland	Dep.of Visceral and Transplant Surgery, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Alagna S, Cossu ML, Masala A, Atzeni MM, Ruggiu M, Satta FM, Fais E, Rovasio PP, Noya G. Evaluation of serum leptin levels and thyroid function in morbidly obese patients treated with bariatric surgery. Eat Weight Disord. 2003 Jun;8(2):95-9. — View Citation

Chikunguwo S, Brethauer S, Nirujogi V, Pitt T, Udomsawaengsup S, Chand B, Schauer P. Influence of obesity and surgical weight loss on thyroid hormone levels. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):631-5; discussion 635-6. — View Citation

Reinehr T, Andler W. Thyroid hormones before and after weight loss in obesity. Arch Dis Child. 2002 Oct;87(4):320-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thyroid hormone levels (change in)		preoperative, 3, 6 and 12 months postoperative	No
Secondary	morphological changes of the thyroid gland		up to 12 months postoperatively	No