The Effect of Bariatric Surgery on Glucose Metabolism

The Effect of Bariatric Surgery on Glucose Metabolism and Kidney Function

This prospective, single arm, longitudinal study aims to assess the effect of bariatric surgery on glucose metabolism and kidney function.

Study Overview

• Status: Unknown
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Bariatric surgery

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yeongkeun Kwon, MD,PhD; Phone Number: +82-10-9329-4183; Email: kukwon@korea.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Yeongkeun Kwon, MD,PhD; Phone Number: +82-10-9329-4183; Email: kukwon@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bariatric surgery patients; Bariatric patients undergoing sleeve gastrectomy or Roux-en-Y gastric bypass	Procedure: Bariatric surgery; Bariatric surgery including sleeve gastrectomy and Roux-en-Y gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with diabetes remission	Remission (complete): Normal measures of glucose metabolism (HbA1c<6%, fasting plasma glucose<100mg/dl) in the absence antidiabetic medication	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with optimal LDL cholesterol control	LDL cholesterol: <100 mg/dL = optimal (or <40 mg/dL if another risk factor is present)	3,6,12 months
Percent excess weight loss	Percent excess weight loss (%EWL) %EWL = [(Initial Weight) - (Postop Weight)]/[(Initial Weight) - (Ideal Weight)]	3,6,12 months
Changes of estimated glomerular filtration rate	Changes of Cystatin C or creatinine based eGFR Changes of urine protein(albumin) creatinine ratio	3,6,12 months
Changes of metabolites profile	Changes of serum diabetes-related metabolites profile including large neutral amino acids, tryptophan-derived metabolites	3,6,12 months
Proportion of patients with hypertension improvement	Improvement: Defined as a decrease in dosage or number of antihypertensive medication or decrease in systolic or diastolic blood pressure (BP) on the same medication (better control).	3,6,12 months

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Principal Investigator: Sungsoo Park, MD,PhD, Korea University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Anticipated): November 18, 2021
• Study Completion (Anticipated): November 18, 2021

Study Registration Dates

• First Submitted: November 17, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: STARDOM-Bari

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No