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Enrolling by invitationNCT03296605Updated Oct 23, 2024

Development of Obesity and Bariatric Surgery

An observational study in Obesity, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-23.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Obesity patients and controls

Inclusion criteria

  1. Body mass index ≥18 kg/m2
  2. already received bariatric surgery or abdonimal surgery

Exclusion criteria

Exclusion Criteria:

  1. acute stroke or acute myocardial infarction in 6 months
  2. autoimmune disease
  3. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
  4. pregnancy
  5. consists with other endocrine diseases
  6. acute infection in2 weeks
  7. cancer
  8. use of antibiotics in 3 months
  9. chronic digestive inflammations 9
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Obesity

    Patients with obesity already received bariatric surgery

  • Healthy control

    Volunteers with normal body weight and already received abdominal surgery

05

What researchers measure

Primary outcomes

  1. Immunity cells

    Ratio of immunity cells in circulating and adipose or liver tissue

    Time frame: up to 5 years

Secondary outcomes

  1. Body weight and height

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

    Time frame: up to 5 years

  2. Insulin

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

    Time frame: up to 5 years

  3. Cytokine

    Cytokines concentrations in circulating and adipose or liver tissue

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: up to 5 years

  9. brain structure and activation in fMRI

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

    Time frame: up to 5 years

06

Study locations

1 site
  • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
    Nanjing, Jiangsu 210008, China
07

References and documents

Publications

  • 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 ↗
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Registry details

Key details

Study ID
NCT03296605
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Zhu DaLong (Director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Sep 28, 2017
Start date
Mar 1, 2017
Primary completion
Mar 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Oct 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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