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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05529563
Enrollment
138
Registered
2022-09-07
Start date
2017-06-01
Completion date
2022-10-31
Last updated
2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Acanthosis nigricans, Morbid obesity, Insulin secretion pattern, Prolactin, Sleeve gastrectomy

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.

Interventions

PROCEDURELSG

LSG

Sponsors

Shen Qu
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Obesity2017-2023It was defined as BMI ≥ 28 kg/m2 according to the diagnostic criteria for obesity in a Chinese population.
A quantitative scale of Acanthosis Nigricans (AN)2017-20230-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.
Insulin secretion patterns2017-2023they 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).

Secondary

MeasureTime frameDescription
Insulin sensitivity2017-2023It derived from the OGTT was estimated by the oral glucose insulin sensitivity (OGIS) index
BMI2017-2023It was calculated as weight (kg) divided by squared height (meters).
the disposition index (DI)2017-2023It was calculated as IGI/HOMA-IR.
Insulinogenic index (IGI)2017-2023It was calculated as :(insulin30min-insulin0min)/ (glucose30min-glucose0min).
a 2-h 75-g oral glucose tolerance test (OGTT)2017-2023It 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.
HOMA-IR2017-2023It was calculated as FPG (mmol/L)×FINS (mU/L)/22.5 (24).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026