Levothyroxine Absorption in Morbidly Obese Patients Before and After Roux-en-Y Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
LEVOTHYROXINE ABSORPTION IN MORBIDLY OBESE PATIENTS BEFORE AND AFTER ROUX-EN-Y BARIATRIC SURGERY INTRODUCTION Levothyroxine sodium (LT4) is an effective drug prescribed as replacement therapy for patients with hypothyroidism, as a controversial suppressive therapy for nodular thyroid disease and after surgical removal of thyroid cancer. Incidence rates of differentiated thyroid cancer of all sizes have increased both in men and women, as have the rates of autoimmune thyroiditis disease. It is estimated that 3.7% of the United States population has hypothyroidism, indicating that millions of people are in continuous use of LT4.
Absorption of LT4 formulations approximates 80% of the oral dose. It is reduced when LT4 is ingested concomitantly with several drugs including aluminum hydroxide, cholestyramine, sucralfate, ferrous sulphate, calcium carbonate, sodium polystyrene sulfonate, as well as with coffee and fiber supplements.
Intestinal absorption of LT4 depends primarily on its dissolution in gastric acid secretion. Therefore, may be affected by H. pylori infection and autoimmune gastritis. There are substantial interindividual variations in LT4 requirements dependent on patients age, gender and body size, with lean body mass being the major determinant of dose correction for LT4. Morbidly obese patients apparently have impaired LT4 absorption.
The prevalence of obesity has increased to epidemic proportions. Effective treatment may be achieved by bariatric surgeries, but these procedures are associated with several morbidities, such as gastrointestinal and nutritional complications. It is plausible to hypothesize that since bariatric interventions (such as Roux-en-Y) reduce gastric hydrochloric acid secretion, they may impair LT4 absorption.
OBJECTIVE The aim of this study was to evaluate the absorption of LT4 tablets in morbidly obese patients before and after bariatric surgery in order to determine the need for adjustment of LT4 doses.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •previous diagnosis of thyroid cancer
- •diabetes mellitus in use of insulin
- •chronic or atrophic gastritis
- •use of medications associated with impaired LT4 absorption.
研究组 & 干预措施
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.
干预措施: Levothyroxine (Drug)
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
干预措施: Levothyroxine (Drug)