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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529563
• Other study ID #: Acanthosis Nigricans
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2022
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: October 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• LSG
LSG

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shen Qu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obesity	It was defined as BMI = 28 kg/m2 according to the diagnostic criteria for obesity in a Chinese population.	2017-2023
Primary	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
Primary	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	BMI	It was calculated as weight (kg) divided by squared height (meters).	2017-2023
Secondary	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
Secondary	HOMA-IR	It was calculated as FPG (mmol/L)×FINS (mU/L)/22.5 (24).	2017-2023
Secondary	Insulin sensitivity	It derived from the OGTT was estimated by the oral glucose insulin sensitivity (OGIS) index	2017-2023
Secondary	Insulinogenic index (IGI)	It was calculated as :(insulin30min-insulin0min)/ (glucose30min-glucose0min).	2017-2023
Secondary	the disposition index (DI)	It was calculated as IGI/HOMA-IR.	2017-2023