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

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.

Study Overview

• Status: Recruiting
• Conditions: Insulin Resistance; Morbid Obesity; Bariatric Surgery Candidate; Insulin Sensitivity; Acanthosis Nigricans
• Intervention / Treatment: Procedure: LSG

• Study Type: Observational
• Enrollment (Anticipated): 138

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200072
    • Recruiting
    • Shanghai Tenth People's Hospital
    • Contact: Shen Qu, PhD; Phone Number: 02166301064; Email: qushencn@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who met the inclusion and exclusion criteria were enrolled.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obesity without AN (OB group) and obesity with AN (AN group); LSG	Procedure: LSG; LSG

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shen Qu

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 3, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Sleeve gastrectomy; Morbid obesity; Prolactin; Acanthosis nigricans; Insulin secretion pattern
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Obesity; Hyperpigmentation; Pigmentation Disorders; Melanosis; Insulin Resistance; Obesity, Morbid; Acanthosis Nigricans
• Other Study ID Numbers: Acanthosis Nigricans

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No