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ObesityNCT03296605

Development of Obesity and Bariatric Surgery

An observational study of Obesity, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This study focus on the cause of obesity and impacts of bariatric surgery on it. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
How many people
150 participants
Where
1 siteChina
Study dates
1 Mar 2017to 30 Jun 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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Obesity patients and controls

Who may be able to join

  • Body mass index ≥18 kg/m2
  • already received bariatric surgery or abdonimal surgery

Who cannot join

  • acute stroke or acute myocardial infarction in 6 months
  • autoimmune disease
  • long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
  • pregnancy
  • consists with other endocrine diseases
  • acute infection in2 weeks
Show all 9Show fewer
  • cancer
  • use of antibiotics in 3 months
  • chronic digestive inflammations 9

Trial locations and contacts

1 site in 1 country.

China1 site

  • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: Impacts of Bariatric Surgery on Obesity in China

This study focus on the cause of obesity and impacts of bariatric surgery on it.

Conditions
Obesity
Keywords
Obesity
Medical subject headings
Obesity

What participants receive

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

Study groups in NCT03296605
Study groupRoleWhat they receive
ObesityPatients with obesity already received bariatric surgery
Healthy controlVolunteers with normal body weight and already received abdominal surgery

What is being measured

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

  1. Immunity cells

    Ratio of immunity cells in circulating and adipose or liver tissue

    Measured: up to 5 years

Secondary outcomes (9)

  1. Body weight and height

    Body weight and height will be combined to report BMI in kg/m^2

    Measured: up to 5 years

  2. Insulin

    Insulin (mIU/L) concentartions in serum and adipose tissue

    Measured: up to 5 years

  3. Cytokine

    Cytokines concentrations in circulating and adipose or liver tissue

    Measured: up to 5 years

  4. Cognitive Assessment (MMSE)

    Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.

    Measured: up to five years

  5. Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.

    Measured: up to 5 years

  6. Cognitive Assessment (RBANS)

    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from 0-800, and the test means better cognition with a higher score.

    Measured: up to 5 years

  7. Cognitive Assessment (processing speed)

    The Trial Making Test (TMT) provides a measure of processing speed, which consists of part A and part B (TMT-A and TMT-B). The time limits for performing the TMT-A and TMT-B are 180 and 300 seconds, respectively. Processing speed is estimated by the sum of the consuming time to complete TMT-A and TMT-B such that less time indicate faster processing speed.

    Measured: up to 5 years

  8. Cognitive Assessment (executive function)

    The Victoria Stroop Color-Word Test is a well-known measure of executive functioning. There are three indices including Stroop-dot, Stroop-word and Stroop-color word in the test. The color task consists of colored dots; the word task comprises ordinary words that are unrelated to the meaning of color; the color-word task consists of words written in color that indicate the meaning of the color, but the color of these words differs from the meaning of the word itself. The participants were asked to quickly read the color of the dots or Chinese words on the cards. The sum of consuming time taken to read the three cards is used as an index of executive function performance. Less time indicates better executive function.

    Measured: up to 5 years

  9. brain structure and activation in fMRI

    All patients underwent odor-induced task fMRI on a 3.0T MR scanner

    Measured: up to 5 years

Timeline

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

  1. First posted28 Sep 2017
  2. Study start1 Mar 2017
  3. Primary completion30 Mar 2025 (estimated)
  4. Study completion30 Jun 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
NCT03296605
Sponsor's protocol ID
AF/SC-08/02.0
Status last verified
Oct 2024
First submitted
12 Sep 2017
Last updated
23 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fang D, Yu X, Zhang P, Feng W, Hong T, Gu T. The beneficial effect of hepatic ER stress-associated protein PDI on obesity-associated glucose dysregulation. Nutr Metab (Lond). 2025 Nov 28;22(1):145. doi: 10.1186/s12986-025-01041-9.

    PubMed 41316343

  • Tang W, Ge K, Shen L, Wang H, Feng W, Sun X, Chu X, Zhu D, Yin H, Bi Y. Th1 bias of liver mucosal-associated invariant T cells promotes hepatic gluconeogenesis in type 2 diabetes mellitus. Diabetes Metab Res Rev. 2023 May;39(4):e3620. doi: 10.1002/dmrr.3620. Epub 2023 Feb 17.

    PubMed 36738300

  • Liu F, He J, Liu B, Zhang P, Wang H, Sun X, Chu X, Guan W, Feng W, Bi Y, Zhu D. Association of Omental Adipocyte Hypertrophy and Fibrosis with Human Obesity and Type 2 Diabetes. Obesity (Silver Spring). 2021 Jun;29(6):976-984. doi: 10.1002/oby.23155. Epub 2021 May 4.

    PubMed 33943025

  • Yuan X, Chen J, Cheng Q, Zhao Y, Zhang P, Shao X, Bi Y, Shi X, Ding Y, Sun X, Xue B. Hepatic expression of Yin Yang 1 (YY1) is associated with the non-alcoholic fatty liver disease (NAFLD) progression in patients undergoing bariatric surgery. BMC Gastroenterol. 2018 Oct 3;18(1):147. doi: 10.1186/s12876-018-0871-2.

    PubMed 30285651

  • Zhang P, Ge Z, Wang H, Feng W, Sun X, Chu X, Jiang C, Wang Y, Zhu D, Bi Y. Prolactin improves hepatic steatosis via CD36 pathway. J Hepatol. 2018 Jun;68(6):1247-1255. doi: 10.1016/j.jhep.2018.01.035. Epub 2018 Feb 13.

    PubMed 29452209

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 9 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 23 Oct 2024. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunity cells (time frame: up to 5 years). 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 NCT03296605, which also lists 5 linked publications.

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 23 Oct 2024.

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