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OpenTrials
Completed

NCT Number: NCT02088190

Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition

The investigators hypothesize that the improvements in insulin sensitivity, beta (β)-cell function, and inflammation will be greater, and the improvement in sarcopenic obesity will be less, in younger versus older individuals after substantial weight loss induced by sleeve gastrectomy bariatric surgery.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

With an aging population that is increasingly susceptible to obesity and obesity-related comorbidities including sarcopenia and diabetes, effective and safe treatment options tailored to the needs of older adults are imperative. While medication and lifestyle interventions generally fail to achieve sustained large-scale weight loss, bariatric surgery is the most effective long-term weight loss treatment for obese patients and improves many of the medical complications associated with obesity. Sleeve gastrectomy (SG) results in substantial weight loss and may be more appropriate for older adults due to its low rate of complications and mortality. Therefore, SG has been proposed as a reasonable primary treatment modality in older obese individuals, with a substantial recent increase in the number of interventions performed. Despite the potential benefits, very little is known of the physiologic and metabolic effects of bariatric surgery, including SG, on glucose homeostasis and muscle physiology in older adults. A fundamental understanding of the effects of excess adiposity and weight loss interventions is of profound importance, especially with emerging evidence that earlier treatment of obesity may delay/prevent many comorbidities. An underlying inflammatory state has been implicated in the pathogenesis of sarcopenia and insulin resistance and may provide an important connection to the age-related declines seen in older obese patients. Therefore, this study aims to evaluate the modifying effect of age and inflammation on the SG-induced changes in body composition, muscle physiology, and insulin sensitivity. This protocol will be conducted in two age cohorts (greater than 60 and less than 50 years old).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 21-80 yrs old
  • BMI ≥ 35 kg/m2
  • Undergoing laparoscopic sleeve gastrectomy (SG)

Exclusion criteria

  • Smokers
  • Presence of diabetes mellitus
  • Taking any medication that might affect metabolism
  • Severe organ dysfunction
  • Pregnant or breastfeeding
  • Prior gastrointestinal surgery that might affect study results
  • Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not an appropriate candidate for this study
  • Weight >450 pounds (Will be unable to fit on the DXA scanner)

Treatment and study plan

Sleeve gastrectomy

Procedure

Type of bariatric surgery

Primary outcomes

  1. Change in Insulin Sensitivity

    Time frame: Change from baseline in Insulin sensitivity at 15% weight loss (up to 4 months after surgery)

    Subjects will undergo a clamp procedure to assess insulin sensitivity at baseline and 15% weight loss after surgery

Secondary outcomes

  1. Change in Beta cell function

    Time frame: Change from baseline to 15% weight loss (up to 4 months after surgery)

    Subjects will undergo a mixed meal tolerance test at baseline and 15% weight loss

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Mar 14, 2014
Registry last updated
Jun 27, 2022

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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