An interventional study of Laboratory evaluations, sleep study and Best Medical Management in Obesity and Type 2 Diabetes Mellitus, sponsored by David Bradley MD. Completed at 1 site in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-21.
Sponsored by David Bradley MD · Not applicable, Interventional, and Diagnostic
Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).
Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with David Bradley MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients elect to treat obesity and type 2 diabetes mellitus through best medical management.
Other: Laboratory evaluations, sleep study · Other: Best Medical Management
Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.
Other: Laboratory evaluations, sleep study · Procedure: Roux-en-Y gastric bypass surgery
Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
Standard of care.
Surgical treatment.
Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.
Time frame: 2 years
Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia
Time frame: 2 years
Improvement in glucose control
Time frame: 2 years
Improvement in control of chronic co-morbidities
Time frame: 2 years
Identify predictors of success with regard to improved co-morbidities and velocity of weight loss
Time frame: 2 years
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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