Morbid ObesityNCT05529563
The Effect of Laparoscopic Sleeve Gastrectomy on Insulin Secretion Pattern in Morbidly Obese Patients With Acanthosis Nigricans
An observational study of Morbid Obesity and Acanthosis Nigricans, run by Shen Qu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Acanthosis Nigricans, Insulin Resistance
- What is being tested?
- LSG
- Type of treatment
- Surgery or procedure
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who met the inclusion and exclusion criteria were enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, 200072
Shen Qu, PhD, 02166301064, qushencn@hotmail.com
About this study
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.
- Conditions
- Morbid Obesity, Acanthosis Nigricans, Insulin Resistance, Insulin Sensitivity, Bariatric Surgery Candidate
- Being tested
- LSG
- Keywords
- Acanthosis nigricans, Morbid obesity, Insulin secretion pattern, Prolactin, Sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid, Acanthosis Nigricans, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSGProcedure or surgery
LSG
| Study group | Role | What they receive |
|---|---|---|
| obesity without AN (OB group) and obesity with AN (AN group) | LSG Receives: Procedure: LSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity
It was defined as BMI ≥ 28 kg/m2 according to the diagnostic criteria for obesity in a Chinese population.
Measured: 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.
Measured: 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).
Measured: 2017-2023
Secondary outcomes (6)
BMI
It was calculated as weight (kg) divided by squared height (meters).
Measured: 2017-2023
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.
Measured: 2017-2023
HOMA-IR
It was calculated as FPG (mmol/L)×FINS (mU/L)/22.5 (24).
Measured: 2017-2023
Insulin sensitivity
It derived from the OGTT was estimated by the oral glucose insulin sensitivity (OGIS) index
Measured: 2017-2023
Insulinogenic index (IGI)
It was calculated as :(insulin30min-insulin0min)/ (glucose30min-glucose0min).
Measured: 2017-2023
the disposition index (DI)
It was calculated as IGI/HOMA-IR.
Measured: 2017-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jun 2017
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Qu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Qu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529563
- Sponsor's protocol ID
- Acanthosis Nigricans
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laparoscopic Sleeve Gastrectomy on Insulin Secretion Pattern in Morbidly Obese Patients With Acanthosis Nigricans
- ClinicalTrials.gov ID
- NCT05529563
- Acronym / sponsor ID
- Acanthosis Nigricans
- Conditions
- Morbid Obesity, Acanthosis Nigricans, Insulin Resistance, Insulin Sensitivity, Bariatric Surgery Candidate
- Keywords
- Acanthosis nigricans, Morbid obesity, Insulin secretion pattern, Prolactin, Sleeve gastrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shen QuUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obesity without AN (OB group) and obesity with AN (AN group) | – | Procedure: LSGLSG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who met the inclusion and exclusion criteria were enrolled.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSGLSG | Procedure or surgery | obesity without AN (OB group) and obesity with AN (AN group) |
Primary outcome
Obesity
Time frame: 2017-2023
It 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)
Time frame: 2017-2023
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.
Insulin secretion patterns
Time frame: 2017-2023
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).
6 secondary outcomes
BMI
Time frame: 2017-2023
a 2-h 75-g oral glucose tolerance test (OGTT)
Time frame: 2017-2023
HOMA-IR
Time frame: 2017-2023
Insulin sensitivity
Time frame: 2017-2023
Insulinogenic index (IGI)
Time frame: 2017-2023
the disposition index (DI)
Time frame: 2017-2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Acanthosis Nigricans, run by Shen Qu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity (time frame: 2017-2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.