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

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT02088190
Collaborator
(none)
11
1
87
0.1

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Change in Insulin Sensitivity [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 The Ohio State University Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University

Investigators

  • Principal Investigator: David P Bradley, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ohio State University
ClinicalTrials.gov Identifier:
NCT02088190
Other Study ID Numbers:
  • ENDO-235
First Posted:
Mar 14, 2014
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022