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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05529563
Other study ID # Acanthosis Nigricans
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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