NCT05529563

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

5.3 years

First QC Date

September 2, 2022

Last Update Submit

September 3, 2022

Conditions

Morbid ObesityAcanthosis NigricansInsulin ResistanceInsulin SensitivityBariatric Surgery Candidate

Keywords

Acanthosis nigricansMorbid obesityInsulin secretion patternProlactinSleeve gastrectomy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • BMI

    2017-2023

  • a 2-h 75-g oral glucose tolerance test (OGTT)

    2017-2023

  • HOMA-IR

    2017-2023

  • Insulin sensitivity

    2017-2023

  • Insulinogenic index (IGI)

    2017-2023

  • +1 more secondary outcomes

Study Arms (1)

obesity without AN (OB group) and obesity with AN (AN group)

LSG

Procedure: LSG

Interventions

LSGPROCEDURE

LSG

obesity without AN (OB group) and obesity with AN (AN group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who met the inclusion and exclusion criteria were enrolled.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, 200072, China

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidAcanthosis NigricansInsulin Resistance

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

June 1, 2017

Primary Completion

October 1, 2022

Study Completion

October 31, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

CN(1)