Clinical trial NCT02088190: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Cognitive Impairment
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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)

Primary outcomes:
measure: Change in Insulin Sensitivity
timeFrame: Change from baseline in Insulin sensitivity at 15% weight loss (up to 4 months after surgery)
Secondary outcomes:
measure: Change in Beta cell function
timeFrame: Change from baseline to 15% weight loss (up to 4 months after surgery)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: David P Bradley, MD
role: PRINCIPAL_INVESTIGATOR
References: