Cortisol and Obesity - A Vicious Cycle? Hypoglycemia After Bariatric Surgery - Association With Cortisol Metabolism?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in serum cortisol during mixed meal test
研究概览
简要总结
The goal of this observational study is to learn about how bariatric surgery affects the metabolism of cortisol.
The main question it aims to answer is whether changes in cortisol contribute to the development of reactive hypoglycemia?
100 individuals who have previously undergone bariatric surgery, are planned to be included.
详细描述
Purpose The project investigates how bariatric surgery affects the metabolism of cortisol. Additionally, it examines whether changes in cortisol contribute to the development of reactive hypoglycemia, a serious complication observed after bariatric surgery.
Study Visits
Visit 1:
At the first visit, participants sign an informed consent form, complete a medical history questionnaire, undergo measurements (height, weight), and have blood samples taken. They also undergo an adrenal stimulation test (ACTH test), receive a continuous glucose monitor (CGM), and complete a questionnaire about hypoglycemia symptoms.
The CGM is a small device that continuously measures blood glucose levels via a tiny sensor placed on the skin, typically on the arm or abdomen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must have undergone one of the following bariatric procedures at least 12 months prior:
- •Roux-en-Y gastric bypass
- •Gastric sleeve
排除标准
- •Pregnancy and breastfeeding
- •Nephrotic syndrome (kidney disease with protein loss in urine), liver cirrhosis, or severe malnutrition, as these conditions reduce cortisol-binding globulin (CBG) levels, affecting total cortisol concentration
- •Use of corticosteroid medications, such as prednisolone
- •Use of opiod-containing medication
- •Use of medications containing estrogen, such as hormone therapy for menopause
- •Known adrenal disease affecting cortisol metabolism, including autonomous cortisol production and Cushing's syndrome
- •Diabetes that does not require medical treatment
- •Previously diagnosed reactive hypoglycemia after bariatric surgery requiring medical treatment
结局指标
主要结局
Changes in serum cortisol during mixed meal test
时间窗: 0, 30, 60, 90, 120, 150, 180 minutes (visit 2)
cortisol at nadir glucose during the mixed meal test - cortisol at the start of the meal test
次要结局
- Cortisol hormone profile(1 hour)
- ACTH test: Test of adrenal function(0, 30 minutes)
- urinary cortisol: Ratio of cortisol/cortisone(24 hour)
研究者
Charlotte Røn Stolberg, MD, PhD
Principal Investigator, Senior Registrar in Endocrinology
Esbjerg Hospital - University Hospital of Southern Denmark