The Effect of Bariatric Surgery on Glucose Metabolism

Bariatric Surgery Candidate Clinical Trial

Official title:

The Effect of Bariatric Surgery on Glucose Metabolism and Kidney Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174768
• Other study ID #: STARDOM-Bari
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: November 18, 2021

Study information

• Verified date: November 2019
• Source: Korea University Anam Hospital
• Contact: Yeongkeun Kwon, MD,PhD
• Phone: +82-10-9329-4183
• Email: kukwon[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• Bariatric surgery
Bariatric surgery including sleeve gastrectomy and Roux-en-Y gastric bypass

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percent excess weight loss	Percent excess weight loss (%EWL) %EWL = [(Initial Weight) - (Postop Weight)]/[(Initial Weight) - (Ideal Weight)]	3,6,12 months
Secondary	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
Secondary	Changes of metabolites profile	Changes of serum diabetes-related metabolites profile including large neutral amino acids, tryptophan-derived metabolites	3,6,12 months
Secondary	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