AzTrials
AzTrials

ObesityNCT05892224

Study on Brain Function of Obesity Classification

An observational study of Obesity and Functional Neuroimaging, run by Shanghai 10th People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study was to investigate the differences and similarities of brain function in patients with four subtypes of obesity, and the relationship between brain function changes and complications after weight loss and metabolic improvement. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Functional Neuroimaging
What is being tested?
Laparoscopic sleeve gastrectomy
Type of treatment
Surgery or procedure
How many people
150 participants
Where
1 siteChina
Study dates
1 Jan 2022to 31 Dec 2025
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: 120 Patients from Shanghai Tenth People's Hospital were enrolled in this study.

Who may be able to join

  • age ranged from 16-65 years old
  • BMI over 37.5kg/m2, or BMI over 32.5kg/m2 with diabetes which meets the recommended cut-off bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

Who cannot join

  • secondary causes of obesity such as hypothalamic obesity, Cushing syndrome, hypophysis dysfunction, etc
  • pregnancy or location
  • contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc
  • severe heart, liver, and kidney dysfunction
  • organic and systemic diseases intolerant of surgery.

Trial locations and contacts

1 site in 1 country.

Shen Qu, Dr. contact

(86)021-66301004

qushencn@hotmail.com

China1 site, 1 recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

    Shen Qu, M.D. Ph.D, 86-21-66302531, qushencn@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Research on Brain Function of Metabolism-based Artificial Intelligence Assisted Clinical Classification of Obesity

The purpose of this study was to investigate the differences and similarities of brain function in patients with four subtypes of obesity, and the relationship between brain function changes and complications after weight loss and metabolic improvement. 120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.

Read the detailed description

Although the investigators have clinically observed significant differences in appetite and metabolic status in patients with the above four types of obesity, the brain functional characteristics of different obesity subtypes and their relationship with metabolic markers are still unclear. Based on this, in this project, the investigators plan to explore further the similarities and differences in brain function in patients with four subtypes of obesity and the relationship between brain function changes after weight loss and metabolic improvement and the occurrence of complications.

120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.

All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, and 12 months after laparoscopic sleeve gastrectomy (LSG). Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative. Resting and task state functional magnetic resonance imaging (fMRI) measurements were performed at baseline for all participants at two-time points before and after meals. Measurements were repeated in obese patients 6 months after surgery.

Being tested
Laparoscopic sleeve gastrectomy
Keywords
obesity, Functional Neuroimaging, Brain, artificial intelligence
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve gastrectomyProcedure or surgery

    Obese patients of different subtypes were all expected to undergo bariatric surgery

Study groups in NCT05892224
Study groupRoleWhat they receive
MHO groupMetabolic healthy obesity
Receives: Procedure: Laparoscopic sleeve gastrectomy
HMO-U groupHypermetabolic obesity-hyperuricemia
Receives: Procedure: Laparoscopic sleeve gastrectomy
HMO-I groupHypermetabolic obesity-hyperinsulinemia
Receives: Procedure: Laparoscopic sleeve gastrectomy
LMO groupHypometabolic obesity
Receives: Procedure: Laparoscopic sleeve gastrectomy
control groupHealthy person

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional magnetic resonance imaging of brain

    The subjects underwent fMRI scans before and after eating. Blood oxygen levels depend on functional brain imaging (Blod-fMRI) to collect the brain's local BLOD response (hemodynamic response) caused by the electrical activity of neurons. The stronger the BLOD response, the more excitability of the local brain.

    A region-of-interest (ROI) approach was applied with the use of masks that were established in an independent study of normal-weight subjects to be markers of satiety or predictors of food choices. ROIs included the left and right ventral striatum (nucleus accumbens), the left and right amygdala, the left and right dorsal striatum (caudate and putamen), the left and right insula, and the medial orbital frontal cortex (mOFC).

    functional connectivity analysis analyzes the compatibity of temporal signals of two or more pairs of brain regions or the differences in the strength of functional connections under different experimental conditions

    Measured: 6 months

Secondary outcomes (33)

  1. BMI

    BMI=weight(kg)/height(m)^2

    Measured: 12 months

  2. Waist/hip Ratio

    WHR(waist-hip ratio)=Waist Circumference in centimeter/Hip Circumference in centimeter

    Measured: 12 months

  3. DXA(dual energy x-ray absorptiometry)

    Dual X-ray Absorptiometry body composition analysis

    Measured: 12 months

  4. Abdominal Fat Measurement

    Abdominal Fat Measurement by B-mode Ultrasound

    Measured: 12 months

  5. FBG

    fasting blood-glucose in mmol/L

    Measured: 12 months

  6. PBG

    postprandial blood-glucose in mmol/L

    Measured: 12 months

  7. FINS

    fasting serum insulin in mU/L

    Measured: 12 months

  8. PINS

    postprandial insulin in mU/L

    Measured: 12 months

  9. ALT

    alanine aminotransferase in U/L

    Measured: 12 months

  10. AST

    aspartate aminotransferase in U/L

    Measured: 12 months

  11. UA

    Uric acid in umol/L

    Measured: 12 months

  12. HOMA-IR

    Homeostatic model assessment insulin resistance index=FBG*FINS/22.5

    Measured: 12 months

  13. HbA1c (%)

    Glycated hemoglobin

    Measured: 12 months

  14. LDL-C

    low-density lipoprotein cholesterol in mmol/L

    Measured: 12 months

  15. HDL-C

    Hight-density lipoprotein cholesterol in mmol/L

    Measured: 12 months

  16. TT

    total testosterone in nmol/L

    Measured: 12 months

  17. SHBG

    sex hormone-binding globulin in nmol/L

    Measured: 12 months

  18. TSH

    thyroid stimulating hormone in μIU/ml

    Measured: 12 months

  19. FT3

    free triiodothyronine in pmol/L

    Measured: 12 months

  20. FT4

    free thyroxine in pmol/L

    Measured: 12 months

  21. FT

    free testosterone (nmol/L)

    Measured: 12 months

  22. DHEAS

    Dehydroepiandrosterone Sulfate (ug/dl)

    Measured: 12 months

  23. PTH

    parathyroid hormone in （ng ／ L）

    Measured: 12 months

  24. 25OHD

    25 hydroxyvitamin D in （nmol ／ L）

    Measured: 12 months

  25. Ca

    serum calcium in (mmol/L)

    Measured: 12 months

  26. GLP-1

    Glucagon-like peptide-1(pmol/L)

    Measured: 12 months

  27. LCN2

    Lipocalin 2 level

    Measured: 12 months

  28. Ghrelin

    Ghrelin level

    Measured: 12 months

  29. Leptin

    Leptin level

    Measured: 12 months

  30. S100

    S100 protein level

    Measured: 12 months

  31. GFAP

    Glial fibrillary acidic protein level

    Measured: 12 months

  32. TEFQ-R21

    The TFEQ-R21 consisted of 21 items rated on a four-point Likert scale. We averaged the scores (ranging from 1 to 4) for the overall items as well as the items within the subdomain of each item, i.e., EE, UE, and CR, where a higher score indicated a more dysfunctional eating behavior.

    Measured: 12 months

  33. HADS

    HADS consists of two subscales: HADS-A, designed to detect anxious states, and HADS-D, designed to detect depressive states. Each subscale consists of seven items with a 4-point ordinal response format. Scores ranges from 0 to 21 in each subscale, with higher scores indicating higher levels of anxious or depressive state. Participants answer each item thinking of how they felt and/or behaved during the past week.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05892224
Sponsor's protocol ID
Brain function in obesity
Status last verified
May 2023
First submitted
10 Mar 2023
Last updated
7 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Functional Neuroimaging, run by Shanghai 10th People's Hospital 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 2 inclusion and 5 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 Jun 2023. 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?

Contact Shen Qu, Dr. ((86)021-66301004, qushencn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional magnetic resonance imaging of brain (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05892224.

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 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Study on Brain Function of Obesity Classification | AzTrials