NCT00871130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

Enrollment Period

9.9 years

First QC Date

March 24, 2009

Last Update Submit

March 27, 2009

Conditions

Keywords

Thyroid glandbariatric surgeryweight lossthyroid hormonesadultmorbid obesitycohort

Outcome Measures

Primary Outcomes (1)

  • thyroid hormone levels (change in)

    preoperative, 3, 6 and 12 months postoperative

Secondary Outcomes (1)

  • morphological changes of the thyroid gland

    up to 12 months postoperatively

Interventions

gastric banding, gastric bypass or vertical gastroplasty either open or laparoscopic or a combination of any

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Patients who underwent bariatric surgery between 1998 and 2007

You may not qualify if:

  • age \>18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep.of Visceral and Transplant Surgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 18023816BACKGROUND
  • 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. doi: 10.1007/BF03324997.

    PMID: 12880185BACKGROUND
  • Reinehr 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.

    PMID: 12244007BACKGROUND

MeSH Terms

Conditions

ObesityThyroid DiseasesWeight LossObesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine System DiseasesBody Weight Changes

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Vanessa Banz, MD

    Dep.of Visceral and Transplant Surgery, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 30, 2009

Study Start

January 1, 1998

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 30, 2009

Record last verified: 2009-03

Locations