Levothyroxine (L-T4) Absorption After Bariatric Surgery (RYS)
This study has been completed.
Sponsor:
University of Sao Paulo
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
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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:
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01189344
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
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 |
| 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 |
Additional relevant MeSH terms:
|
Obesity, Morbid Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on September 30, 2016