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Enrolling by Invitation

NCT Number: NCT03296605

Development of Obesity and Bariatric Surgery

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

Enrolling by Invitation

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • cancer
  • use of antibiotics in 3 months
  • chronic digestive inflammations 9

Treatment and study plan

Primary outcomes

  1. Immunity cells

    Time frame: up to 5 years

    Ratio of immunity cells in circulating and adipose or liver tissue

Secondary outcomes

  1. Body weight and height

    Time frame: up to 5 years

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

  2. Insulin

    Time frame: up to 5 years

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

  3. Cytokine

    Time frame: up to 5 years

    Cytokines concentrations in circulating and adipose or liver tissue

  4. Cognitive Assessment (MMSE)

    Time frame: up to five years

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

  5. Cognitive Assessment (MoCA)

    Time frame: up to 5 years

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

  6. Cognitive Assessment (RBANS)

    Time frame: up to 5 years

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

  7. Cognitive Assessment (processing speed)

    Time frame: up to 5 years

    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.

  8. Cognitive Assessment (executive function)

    Time frame: up to 5 years

    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.

  9. brain structure and activation in fMRI

    Time frame: up to 5 years

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

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

Impacts of Bariatric Surgery on Obesity in China

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2017
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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