Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Insulin Resistance Cognitive Impairment Procedure: Sleeve gastrectomy

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
Study Start Date : April 2014
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Age group 1
Age > 60 years old
 Procedure: Sleeve gastrectomy
Type of bariatric surgery
Age group 2
Age < 60 years old
 Procedure: Sleeve gastrectomy
Type of bariatric surgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in Beta cell function [ Time Frame: Change from baseline to 15% weight loss (up to 4 months after surgery) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088190


Contacts
Layout table for location contacts
Contact: Andrew Suzo 614-293-9964 Andrew.Suzo@osumc.edu

Locations
Layout table for location information
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: David Bradley, MD, MS         
Sponsors and Collaborators
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: David P Bradley, MD Ohio State University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: David Bradley MD, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02088190    
Other Study ID Numbers: ENDO-235
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases