Thyroid FunctionNCT00871130
The Effect of Bariatric Surgery on Thyroid Function and Morphology
An observational study of Thyroid Function and Obesity, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Function, Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 1998to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Patients who underwent bariatric surgery between 1998 and 2007
Who cannot join
- age >18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep.of Visceral and Transplant Surgery, Bern University Hospital
Bern, 3010
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Function, Obesity
- Being tested
- Bariatric surgery
- Keywords
- Thyroid gland, bariatric surgery, weight loss, thyroid hormones, adult, morbid obesity, cohort
- Medical subject headings
- Obesity, Thyroid Diseases, Weight Loss, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
gastric banding, gastric bypass or vertical gastroplasty either open or laparoscopic or a combination of any
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid hormone levels (change in)
Measured: preoperative, 3, 6 and 12 months postoperative
Secondary outcomes (1)
morphological changes of the thyroid gland
Measured: up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJan 1998
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Vanessa Banz, MD, Principal investigator, Dep.of Visceral and Transplant Surgery, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871130
- Sponsor's protocol ID
- KEK_13_01_09
- Status last verified
- Mar 2009
- First submitted
- 24 Mar 2009
- Last updated
- 30 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/j.soard.2007.07.011.
PubMed 18023816Alagna 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. doi: 10.1007/BF03324997.
PubMed 12880185Reinehr T, Andler W. Thyroid hormones before and after weight loss in obesity. Arch Dis Child. 2002 Oct;87(4):320-3. doi: 10.1136/adc.87.4.320.
PubMed 12244007
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bariatric Surgery on Thyroid Function and Morphology, a Retrospective Study
- ClinicalTrials.gov ID
- NCT00871130
- Acronym / sponsor ID
- KEK_13_01_09
- Conditions
- Thyroid Function, Obesity
- Keywords
- Thyroid gland, bariatric surgery, weight loss, thyroid hormones, adult, morbid obesity, cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Patients who underwent bariatric surgery between 1998 and 2007
Key exclusion criteria (1 listed)
- age >18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgerygastric banding, gastric bypass or vertical gastroplasty either open or laparoscopic or a combination of any | Procedure or surgery | – |
Primary outcome
thyroid hormone levels (change in)
Time frame: preoperative, 3, 6 and 12 months postoperative
1 secondary outcome
morphological changes of the thyroid gland
Time frame: up to 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2009.
- Background: PubMed 18023816Chikunguwo 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. doi: 10.1016/j.soard.2007.07.011.
- Background: PubMed 12880185Alagna 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. doi: 10.1007/BF03324997.
- Background: PubMed 12244007Reinehr T, Andler W. Thyroid hormones before and after weight loss in obesity. Arch Dis Child. 2002 Oct;87(4):320-3. doi: 10.1136/adc.87.4.320.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Banz, MD principal investigator
Dep.of Visceral and Transplant Surgery, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Function and Obesity, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thyroid hormone levels (change in) (time frame: preoperative, 3, 6 and 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871130, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2009.