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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02088190
Other study ID # ENDO-235
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date July 2021

Study information

Verified date June 2022
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date July 2021
Est. primary completion date November 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 80 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sleeve gastrectomy
Type of bariatric surgery

Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Insulin Sensitivity Subjects will undergo a clamp procedure to assess insulin sensitivity at baseline and 15% weight loss after surgery Change from baseline in Insulin sensitivity at 15% weight loss (up to 4 months after surgery)
Secondary Change in Beta cell function Subjects will undergo a mixed meal tolerance test at baseline and 15% weight loss Change from baseline to 15% weight loss (up to 4 months after surgery)
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