Levothyroxine (L-T4) Absorption After Bariatric Surgery (RYS)

This study has been completed.

Sponsor:

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01189344

First received: August 23, 2010

Last updated: August 25, 2010

Last verified: June 2007

History of Changes

Purpose

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.

Condition	Intervention
Morbid Obesity	Drug: Levothyroxine


Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Levothyroxine Absorption in Morbidly Obese Patients Before and After Roux-en-Y Bariatric Surgery

Resource links provided by NLM:

MedlinePlus related topics: Weight Loss Surgery

Drug Information available for: Levothyroxine Levothyroxine sodium

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:


Enrollment:	30
Study Start Date:	September 2007
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Not surgical group 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 600 µg of oral levothyroxine(LT4. Blood samples were collected before and after LT4 administration
Experimental: Surgical group 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 600 µg of oral levothyroxine(LT4. Blood samples were collected before and after LT4 administration

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

morbidly obese individual (body mass index (BMI)≥40 Kg/m2)
individuals for whom bariatric surgery is indicated
patients who had undergone Roux-en-Y bariatric surgery 2 to 3 months before inclusion in the study

Exclusion Criteria:

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01189344

Locations


Brazil
Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil

Sponsors and Collaborators

University of Sao Paulo

More Information

No publications provided


Responsible Party:	Geraldo Medeiros-Neto, University of São Paulo Medical School
ClinicalTrials.gov Identifier:	NCT01189344 History of Changes
Other Study ID Numbers:	1039/07
Study First Received:	August 23, 2010
Last Updated:	August 25, 2010
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:


Obesity LT4 Absorption Thyroid function

ClinicalTrials.gov processed this record on February 27, 2015

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