NCT04174768

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

November 17, 2019

Last Update Submit

November 20, 2019

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Proportion of patients with optimal LDL cholesterol control

    3,6,12 months

  • Percent excess weight loss

    3,6,12 months

  • Changes of estimated glomerular filtration rate

    3,6,12 months

  • Changes of metabolites profile

    3,6,12 months

  • Proportion of patients with hypertension improvement

    3,6,12 months

Study Arms (1)

Bariatric surgery patients

EXPERIMENTAL

Bariatric patients undergoing sleeve gastrectomy or Roux-en-Y gastric bypass

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

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

Bariatric surgery patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Sungsoo Park, MD,PhD

    Korea University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeongkeun Kwon, MD,PhD

CONTACT

+82-10-9329-4183kukwon@korea.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2019

First Posted

November 22, 2019

Study Start

November 19, 2018

Primary Completion

November 18, 2021

Study Completion

November 18, 2021

Last Updated

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)