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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189344
First Posted: August 26, 2010
Last Update Posted: August 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  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: None (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:


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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189344


Locations
Brazil
Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications:
Responsible Party: Geraldo Medeiros-Neto, University of São Paulo Medical School
ClinicalTrials.gov Identifier: NCT01189344     History of Changes
Other Study ID Numbers: 1039/07
First Submitted: August 23, 2010
First Posted: August 26, 2010
Last Update Posted: August 26, 2010
Last Verified: June 2007

Keywords provided by University of Sao Paulo:
Obesity
LT4
Absorption
Thyroid function

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms