The Effect of Laparoscopic Sleeve Gastrectomy on Insulin Secretion Pattern in Morbidly Obese Patients With Acanthosis Nigricans

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Laparoscopic Sleeve Gastrectomy on Insulin Secretion Pattern in Morbidly Obese Patients With Acanthosis Nigricans

Conditions
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Morbid Obesity, Acanthosis Nigricans, Insulin Resistance, Insulin Sensitivity, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: LSG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| obesity without AN (OB group) and obesity with AN (AN group)<br>LSG | Procedure: LSG<br>* LSG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity | It was defined as BMI ≥ 28 kg/m2 according to the diagnostic criteria for obesity in a Chinese population. | 2017-2023 | 
| A quantitative scale of Acanthosis Nigricans (AN) | 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. | 2017-2023 | 
| Insulin secretion patterns | 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). | 2017-2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | It was calculated as weight (kg) divided by squared height (meters). | 2017-2023 | 
| a 2-h 75-g oral glucose tolerance test (OGTT) | It was performed after an overnight fasting in each patient pre- and 12 months pro-LSG, and blood samples were taken at 0, 30, 60, 120, and 180 min to determine the concentrations of plasma glucose and insulin. | 2017-2023 | 
| HOMA-IR | It was calculated as FPG (mmol/L)×FINS (mU/L)/22.5 (24). | 2017-2023 | 
| Insulin sensitivity | It derived from the OGTT was estimated by the oral glucose insulin sensitivity (OGIS) index | 2017-2023 | 
| Insulinogenic index (IGI) | It was calculated as :(insulin30min-insulin0min)/ (glucose30min-glucose0min). | 2017-2023 | 
| the disposition index (DI) | It was calculated as IGI/HOMA-IR. | 2017-2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid obesity, Acanthosis nigricans, Insulin secretion pattern, Prolactin, Sleeve gastrectomy