ObesityLABS-3NCT02985853
Longitudinal Assessment of Bariatric Surgery Sub-Study
An observational study of Obesity and Diabetes Mellitus, run by Oregon Health and Science University.
Trial summary
The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Sep 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.
Who may be able to join
- Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
- Enrollment in LABS-1 or LABS-2.
- Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
- Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
- Adequate IV access.
Who cannot join
- Informed consent not obtained.
- Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
- Creatinine greater than 1.7.
- Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
- Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).
About this study
Official title: Longitudinal Assessment of Bariatric Surgery Sub-Study: A Prospective, Longitudinal Cohort Study of the Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery (LABS-3 DIABETES)
The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.
Read the detailed description
The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced by the changes in incretin function, together with improvement in insulin resistance induced by weight loss, normalize glucose homeostasis in type 2 DM.
Funds are not available to pay for the surgery for patients, only to address research questions.
- Conditions
- Obesity, Diabetes Mellitus
- Medical subject headings
- Obesity, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight measurements will take place at every visit, up to 72 months after bariatric surgery.
Measured: Up to 72 months
Capillary Blood Glucose
Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
Measured: Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMar 2008
- Primary completion15 Feb 2021
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Purnell, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985853
- Sponsor's protocol ID
- IRB00003207
- Other IDs
- U01DK066557, U01DK066555-08
- Acronym
- LABS-3
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2016
- Last updated
- 16 Dec 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Bariatric Surgery Sub-Study: A Prospective, Longitudinal Cohort Study of the Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery (LABS-3 DIABETES)
- ClinicalTrials.gov ID
- NCT02985853
- Acronym / sponsor ID
- LABS-3 / IRB00003207
- Conditions
- Obesity, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2008 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 7 Dec 2016 (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 goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.
Detailed description
The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced by the changes in incretin function, together with improvement in insulin resistance induced by weight loss, normalize glucose homeostasis in type 2 DM.
Funds are not available to pay for the surgery for patients, only to address research questions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.
Key inclusion criteria (5 listed)
- Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
- Enrollment in LABS-1 or LABS-2.
- Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
- Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
- Adequate IV access.
Key exclusion criteria (5 listed)
- Informed consent not obtained.
- Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
- Creatinine greater than 1.7.
- Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
- Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight
Time frame: Up to 72 months
Weight measurements will take place at every visit, up to 72 months after bariatric surgery.
Capillary Blood Glucose
Time frame: Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes Mellitus, run by Oregon Health and Science University.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Weight (time frame: Up to 72 months). The study lists 2 primary outcomes in all. 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 16 Dec 2022.