NCT04174768UnknownNot Applicable
The Effect of Bariatric Surgery on Glucose Metabolism and Kidney Function
Korea University Anam Hospital1 site in 1 country50 target enrollmentStarted: November 19, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Proportion of patients with diabetes remission
Study Overview
Brief Summary
This prospective, single arm, longitudinal study aims to assess the effect of bariatric surgery on glucose metabolism and kidney function.
Detailed Description
In recent years, it has become apparent that bariatric surgery not only promote dramatic weight loss but improve or eliminate type 2 diabetes (T2D). Furthermore, it has become increasingly clear that glucose homeostasis, which is mainly determined based on insulin secretion and insulin resistance, improves through mechanisms additional to the secondary consequences of weight reduction. We aims to assess the effect of bariatric surgery on glucose control and kidney function, and excavate potential mechanism for those effects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥20 years old
- •body mass index ≥27.5 kg/m2, in case of type 2 diabetes
- •body mass index ≥35 kg/m2, in case of non-type 2 diabetes
Exclusion Criteria
- •Prior complex gastrointestinal surgery, including that of the stomach, small intestine, large intestine, bile duct, pancreas, and spleen; Nissen, and trauma (except hemorrhoidectomy, herniorrhaphy, and appendectomy)
- •Abdominal, thoracic, pelvic, and/or obstetric-gynecologic surgery within 3 months or at the discretion of the Investigator
- •Cardiovascular conditions including significant known coronary artery disease (CAD), uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension (defined as medially treated with the mean of three separate measurements systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
- •Subjects with CAD who were successfully treated with coronary artery bypass graft or percutaneous coronary intervention within 3 months and who have no evidence of active ischemia are eligible
- •Kidney diseases including renovascular hypertension, renal artery stenosis, or end-stage renal disease
- •Known history of chronic liver diseases including liver cirrhosis and alpha-1-antitrypsin deficiency
- •Gastrointestinal disorders including a known history of celiac disease or any other malabsorptive disorders or inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •Psychiatric disorders including dementia, active psychosis, history of suicide attempts, and alcohol or drug abuse within 12 months
- •Severe pulmonary disease defined as forced expiratory volume at one second <50% of the predicted value
- •Anemia defined as hemoglobin <8 in females and 10 in males
- •Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage 1 cancer that was successfully treated are eligible based on the Investigator's discretion
- •Any condition or major illness that in the Investigator's judgement places the subject at undue risk by participating in the study
- •Pregnancy
- •Unable to understand the risks, realistic benefits, and compliance requirements of each program
- •Use of investigational therapy or participation in any other clinical trial within 3 months
- •Plans to move outside South Korea within the next 2 years
Arms & Interventions
Bariatric surgery patients
Experimental
Bariatric patients undergoing sleeve gastrectomy or Roux-en-Y gastric bypass
Intervention: Bariatric surgery (Procedure)
Outcomes
Primary Outcomes
Proportion of patients with diabetes remission
Time Frame: 12 months
Remission (complete): Normal measures of glucose metabolism (HbA1c\<6%, fasting plasma glucose\<100mg/dl) in the absence antidiabetic medication
Secondary Outcomes
- Percent excess weight loss(3,6,12 months)
- Proportion of patients with hypertension improvement(3,6,12 months)
- Proportion of patients with optimal LDL cholesterol control(3,6,12 months)
- Changes of estimated glomerular filtration rate(3,6,12 months)
- Changes of metabolites profile(3,6,12 months)
Investigators
Sungsoo Park
Professor
Korea University Anam Hospital
Study Sites (1)
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