The Effect of Laparoscopic Sleeve Gastrectomy on Insulin Secretion Pattern in Morbidly Obese Patients With Acanthosis Nigricans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Insulin secretion patterns
研究概览
简要总结
Acanthosis nigricans (AN) is increasing in its prevalence and is the most prevalent cutaneous manifestation in individuals with obesity. Insulin resistance or hyperinsulinemia is the main pathophysiological mechanism of obesity-related AN. However, the effect of laparoscopic sleeve gastrectomy (LSG) on insulin secretion pattern in Chinese morbidly obese patients with AN is unknown. In these study, the investigators aimed to explore the insulin secretion patterns in Chinese morbidly obese patients with Acanthosis nigricans (AN) and their alterations after LSG.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 to 65 years
- •BMI equal or greater than 35 kg/m2
- •completed a 75-g OGTT and insulin release assay
- •eligible for the 12-month follow-up.
排除标准
- •severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism
- •mental illness
- •genetic disease
- •current or previous treatment that might affect the sex hormones and insulin secretion
- •gestation or lactation
- •loss to follow-up, or withdrawal from the study
- •unable to understand and comply with the study protocol.
结局指标
主要结局
Insulin secretion patterns
时间窗: 2017-2023
they were derived from the peak time of insulin secretion during OGTT: Type I (peak time at 30 or 60 min) and Type II (peak time at 120 or 180 min).
Obesity
时间窗: 2017-2023
It was defined as BMI ≥ 28 kg/m2 according to the diagnostic criteria for obesity in a Chinese population.
A quantitative scale of Acanthosis Nigricans (AN)
时间窗: 2017-2023
0-absent: not detectable on close inspection; 1-present: clearly present on close visual inspection, not visible to the casual observer, extent not measurable; 2-mild: limited to the base of the skull, does not extend to the lateral margins of the neck (usually \<3 inches in breadth); 3-moderate: extending to the lateral margins of the neck (posterior border of the sternocleidomastoid, usually 3-6 inches), should not be visible when the participant is viewed from the front; 4-severe: extending anteriorly (\>6 inches), visible when the participant is viewed from the front.
次要结局
- BMI(2017-2023)
- Insulinogenic index (IGI)(2017-2023)
- Insulin sensitivity(2017-2023)
- a 2-h 75-g oral glucose tolerance test (OGTT)(2017-2023)
- HOMA-IR(2017-2023)
- the disposition index (DI)(2017-2023)
研究者
Shen Qu
Principle investigator
Shanghai 10th People's Hospital