The Effect of Bariatric Surgery on Glucose Metabolism

November 20, 2019 updated by: Sungsoo Park, Korea University Anam Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with optimal LDL cholesterol control
Time Frame: 3,6,12 months
LDL cholesterol: <100 mg/dL = optimal (or <40 mg/dL if another risk factor is present)
3,6,12 months
Percent excess weight loss
Time Frame: 3,6,12 months
Percent excess weight loss (%EWL) %EWL = [(Initial Weight) - (Postop Weight)]/[(Initial Weight) - (Ideal Weight)]
3,6,12 months
Changes of estimated glomerular filtration rate
Time Frame: 3,6,12 months
Changes of Cystatin C or creatinine based eGFR Changes of urine protein(albumin) creatinine ratio
3,6,12 months
Changes of metabolites profile
Time Frame: 3,6,12 months
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
Time Frame: 3,6,12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sungsoo Park, MD,PhD, Korea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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