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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02088190
Enrollment
11
Registered
2014-03-14
Start date
2014-04-30
Completion date
2021-07-31
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Insulin Resistance

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).

Interventions

PROCEDURESleeve gastrectomy

Type of bariatric surgery

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Insulin SensitivityChange 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

MeasureTime frameDescription
Change in Beta cell functionChange 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026