Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes
NCT ID: NCT01278823
Last Updated: 2019-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
18 participants
INTERVENTIONAL
2011-01-31
2017-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
NCT02762708
Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes
NCT02328599
Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes
NCT03955952
Effect of Bariatric Surgery on Gut Hormones Production and Cure of Type 2 Diabetes Mellitus
NCT01251016
Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
NCT02729246
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The objective of this application is to evaluate the effects of RYGB surgery on glycemic control and underlying mechanisms that contribute to T2DM in obese subjects (BMI: 30-40 kg/m2). Our central hypothesis is that RYGB surgery will reduce hyperglycemia via reversal of beta-cell dysfunction and decrease hepatic and peripheral insulin resistance. The approach requires a 12-month randomized controlled trial. The rationale is based on data showing that RYGB lowers fasting and postprandial glucose, and increases the GLP-1 response to a meal. However, the therapeutic efficacy of RYGB surgery in obesity-related T2DM needs to be demonstrated in a randomized trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
surgery
Surgery: laparoscopic roux en y gastric bypass operation
laparoscopic roux en y gastric bypass operation
roux en y gastric bypass operation
Medical treatment
Medical Treatment: Comprehensive medical management of diabetes including medications, diet intervention, lifestyle modification, exercise regimen
medical management
latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laparoscopic roux en y gastric bypass operation
roux en y gastric bypass operation
medical management
latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 to 60 years old
* BMI 27-43
* type 2 diabetes
* willing to participate in either study arm
* understand and comply with requirements of each arm
* not pregnant
* willing to use reliable birth control for duration of study
Exclusion Criteria
* prior complex abdominal surgery
* abdominal, thoracic, pelvic, obstetrical surgery within last 6 months
* significant cardiovascular disease
* kidney disease with a creatinine greater than or equal to 1.8 mg/dl
* chronic liver disease except for NAFLD/NASH
* celiac, malabsorptive, inflammatory bowel disorders
* psychiatric disorders requiring 3 or more medications
* pregnancy
* cancer except squamous or basal cell skin cancer or cancer in remission
* anticoagulation therapy that can't be stopped for surgery
* clotting disorders
* severe pulmonary disease
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Cleveland Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Philip Schauer
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John Kirwan, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Bariatric and Metabolic Institute, Department of Pathobiology
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kirwan JP, Axelrod CL, Kullman EL, Malin SK, Dantas WS, Pergola K, Del Rincon JP, Brethauer SA, Kashyap SR, Schauer PR. Foregut Exclusion Enhances Incretin and Insulin Secretion After Roux-en-Y Gastric Bypass in Adults With Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4192-e4201. doi: 10.1210/clinem/dgab255.
Related Links
Access external resources that provide additional context or updates about the study.
Cleveland Clinic Bariatric and Metabolic Institute web site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.