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

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ClinicalTrials.gov Identifier: NCT02088190
Recruitment Status : Recruiting
First Posted : March 14, 2014
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
David Bradley MD, Ohio State University

Tracking Information
First Submitted Date March 11, 2014
First Posted Date March 14, 2014
Last Update Posted Date February 24, 2021
Study Start Date April 2014
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 12, 2014)
Change in Beta cell function [ Time Frame: Change from baseline to 15% weight loss (up to 4 months after surgery) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
Official Title Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
Brief Summary 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.
Detailed Description 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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients scheduled to undergo laparoscopic sleeve gastrectomy (SG) at The Ohio State University (OSU) Wexner Medical Center will be divided into two cohorts: 1). Greater than or equal to 60 years of age and 2). Less than 60 years of age.
Condition
  • Insulin Resistance
  • Cognitive Impairment
Intervention Procedure: Sleeve gastrectomy
Type of bariatric surgery
Study Groups/Cohorts
  • Age group 1
    Age > 60 years old
    Intervention: Procedure: Sleeve gastrectomy
  • Age group 2
    Age < 60 years old
    Intervention: Procedure: Sleeve gastrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 12, 2014)
22
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Andrew Suzo 614-293-9964 Andrew.Suzo@osumc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02088190
Other Study ID Numbers ENDO-235
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party David Bradley MD, Ohio State University
Study Sponsor Ohio State University
Collaborators Not Provided
Investigators
Principal Investigator: David P Bradley, MD Ohio State University
PRS Account Ohio State University
Verification Date February 2021