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

Brief Title

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

Official Title

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

Brief 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.
    



Study Type

Observational


Primary Outcome

Obesity

Secondary Outcome

 BMI

Condition

Morbid Obesity

Intervention

LSG

Study Arms / Comparison Groups

 obesity without AN (OB group) and obesity with AN (AN group)
Description:  LSG

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

138

Start Date

June 1, 2017

Completion Date

October 31, 2022

Primary Completion Date

October 1, 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05529563

Organization ID

Acanthosis Nigricans


Responsible Party

Sponsor-Investigator

Study Sponsor

Shen Qu


Study Sponsor

, , 


Verification Date

September 2022