Insulin ResistanceNCT02088190
Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
An observational study of Insulin Resistance and Cognitive Impairment, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Cognitive Impairment
- What is being tested?
- Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 21-80 yrs old
- BMI ≥ 35 kg/m2
- Undergoing laparoscopic sleeve gastrectomy (SG)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Insulin Resistance, Cognitive Impairment
- Being tested
- Sleeve gastrectomy
- Medical subject headings
- Insulin Resistance, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Type of bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Age group 1 | Age > 60 years old Receives: Procedure: Sleeve gastrectomy | |
| Age group 2 | Age < 60 years old Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity
Subjects will undergo a clamp procedure to assess insulin sensitivity at baseline and 15% weight loss after surgery
Measured: Change from baseline in Insulin sensitivity at 15% weight loss (up to 4 months after surgery)
Secondary outcomes (1)
Change in Beta cell function
Subjects will undergo a mixed meal tolerance test at baseline and 15% weight loss
Measured: Change from baseline to 15% weight loss (up to 4 months after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2018
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Bradley, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088190
- Sponsor's protocol ID
- ENDO-235
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2014
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
- ClinicalTrials.gov ID
- NCT02088190
- Acronym / sponsor ID
- ENDO-235
- Conditions
- Insulin Resistance, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age group 1 | – | Procedure: Sleeve gastrectomyAge > 60 years old |
| Age group 2 | – | Procedure: Sleeve gastrectomyAge < 60 years old |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 21-80 yrs old
- BMI ≥ 35 kg/m2
- Undergoing laparoscopic sleeve gastrectomy (SG)
Key exclusion criteria (8 listed)
- Smokers
- Presence of diabetes mellitus
- Taking any medication that might affect metabolism
- Severe organ dysfunction
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve gastrectomyType of bariatric surgery | Procedure or surgery | Age group 1, Age group 2 |
Primary outcome
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
1 secondary outcome
Change in Beta cell function
Time frame: Change from baseline to 15% weight loss (up to 4 months after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P Bradley, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Cognitive Impairment, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Sensitivity (time frame: Change from baseline in Insulin sensitivity at 15% weight loss (up to 4 months after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.