NCT01189344

Brief Summary

Intestinal absorption of levothyroxine (LT4) tablets depends on its dissolution in gastric acid secretion, which is reduced after bariatric interventions. Impaired LT4 absorption due to low gastric dissolution has been reported in patients with atrophic or chronic gastritis. The objective of this study is to evaluate the absorption of LT4 tablets in morbidly obese patients before and after Roux-en-Y bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
Last Updated

August 26, 2010

Status Verified

June 1, 2007

Enrollment Period

2.8 years

First QC Date

August 23, 2010

Last Update Submit

August 25, 2010

Conditions

Morbid Obesity

Keywords

ObesityLT4AbsorptionThyroid function

Study Arms (2)

Not surgical group

EXPERIMENTAL

The Nos surgical (NS) group includes 15 patients for whom bariatric surgery is planned. Body mass index (BMI) of this group of patients is ≥40 Kg/m2.

Drug: Levothyroxine

Surgical group

EXPERIMENTAL

The Surgical (S) group includes 15 patients who had undergone Roux-en-Y bariatric surgery 2 to 3 months before inclusion in the study

Drug: Levothyroxine

Interventions

LevothyroxineDRUG

600 µg of oral levothyroxine(LT4. Blood samples were collected before and after LT4 administration

Not surgical groupSurgical group

Eligibility Criteria

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

You may qualify if:

  • morbidly obese individual (body mass index (BMI)≥40 Kg/m2)
  • individuals for whom bariatric surgery is indicated

You may not qualify if:

  • previous diagnosis of thyroid cancer
  • diabetes mellitus in use of insulin
  • chronic or atrophic gastritis
  • use of medications associated with impaired LT4 absorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Sherman SI, Malecha SE. Absorption and Malabsorption of Levothyroxine Sodium. Am J Ther. 1995 Oct;2(10):814-818. doi: 10.1097/00045391-199510000-00014. No abstract available.

    PMID: 11854792BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidObesity

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 26, 2010

Study Start

September 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 26, 2010

Record last verified: 2007-06

Locations

BR(1)