Hospital-based Diabetes Prevention Study in Korea

July 21, 2017 updated by: Jeong-taek Woo

Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study

The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

744

Phase

  • Phase 4

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 Backup

Study Locations

      • Seoul, Korea, Republic of, 02447
        • Recruiting
        • Kyunghee University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeong-taek Woo, MD, PhD
        • Sub-Investigator:
          • Suk Chon, MD, PhD
        • Sub-Investigator:
          • Sang Youl Rhee, MD, PhD

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

Ages Eligible for Study

31 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 30<Age<71
  2. BMI≥23 kg/m2
  3. '75g Oral glucose tolerance 2 hours after the test Blood glucose140~199mg/dL' or 'Fasting Blood Sugar 110~125 mg/dL' or 'HbA1c 5.7%~6.4%'

Exclusion Criteria:

  1. Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
  2. Type 2 Diabetes Mellitus

    • Who diagnosed with Diabetes Mellitus except for maternity period.
    • Who have had drugs for Diabetes Mellitus(hypoglycemic agent or insulin) except for maternity period.
    • Fasting Glucose≥ 126 mg/dL
    • 75g Oral glucose tolerance 2 hours after the Blood glucose ≥ 200 mg/dL
    • HbA1c ≥ 6.5%
  3. Who life expectancy is short.

    • Cardiac history

      • History of severe cardiovascular disease within the last 6 months (cerebral hemorrhage, stroke, myocardial infarction, angina pectoris, heart failure, etc.)
      • Systolic blood pressure >180 mmHg or Diastolic blood pressure >105 mmHg
      • aortic stenosis
      • Left bundle branch block or Third degree AV block
    • Who had been diagnosed and treated for malignant tumors including leukemia and lymphoma within the last 5 years
    • Abnormal renal function (Creatinine ≥ 1.4 mg/dL (male) or ≥ 1.3 mg/dL (female) or Urine Protein ≥ 2 +)
    • Anemia(Hematocrit <36%((male) or><33%(female)) ⑤ Cirrhosis or chronic active hepatitis (AST/ALT>3UNL)
    • Acute gastrointestinal disease (pancreatitis, infectious intestinal disease)
    • Who is scheduled major surgery within the last 3 to 6 months or just after the surgery.
    • Chronic infection (HIV, active tuberculosis, etc.)
    • Pulmonary patients who rely on oxygen or daily bronchodilators
  4. Who is judged to be able to influence the clinical trial by investigator.

    • Who can not communicate
    • Those with psychiatric or cognitive impairment that may affect the compliance of the clinical trial
    • Those who do not agree to the treatment group allocation by random assignment
    • Those who participate in other studies that may interfere with the clinical trial
    • Those who lost weight by more than 10% during the past 6 months, excluding weight loss after giving birth
    • Those who can not have normal walking or exercise
    • Women who are pregnant
    • Those who are currently pregnant or who are within the last 3 months after giving birth
    • Those planning pregnancy during the clinical trial period
    • Those who have a history of drug and alcohol abuse (acute, chronic) within the last 2 years
    • Those who are not appropriate or unreliable for clinical trials at the discretion of the tester
  5. Who taking medication or medical condition that may affect the diagnosis of diabetes

    • Thiazide diuretics
    • Systemic beta blockers
    • Taking Niacin for the treatment of neutropenic depression
    • Possibility of taking or injecting a systemic steroid preparation
    • Taking a serotonin reuptake inhibitor (SSRI) for weight loss purpose.
    • Taking medicine for weight loss
    • Hormone status is not appropriate during thyroid hormone replacement therapy (TSH abnormal range) (If thyroid hormone therapy is stable for more than 3 months and TSH is normal, the patient can participate in)
    • Others with other endocrine diseases (eg Cushing's syndrome, acromegaly)
    • During treatment, fasting plasma triglyceride> 600 mg / dL

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional Management
A patient will receive 30 minutes of individual education from the investigator, based on the standard guidelines of the Korean Diabetes Association. And will be followed up every 6 months for 36 months.
Experimental: Life style modification

Proceed according to the Intervention Protocol developed by the Nutrition Committee of the Korean Diabetes Association. Aim to lose more than 5% of weight within 6 months, and then aim to keep weight loss constantly. After randomization, the diabetes educator team (physician / nurse / dietician) applies the intervention program for exercise therapy and diet therapy, and manages it through online education (telephone visit) and offline education (institution visit).

  • Exercise: Moderate or abnormal exercise for more than 150 minutes per week (moderate or abnormal exercise for 30 minutes or more per day)
  • Diet remedies: Train Calorie intake, nutrient intake and Monitoring.
Active Comparator: Metformin
After randomization, take 250 mg once a day for 2 weeks. If there is no side effect, take 500 mg once a day for 2 weeks. If there are no side effects, the maximum dose can be increased to 1000mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of Diabetes Mellitus after randomization
Time Frame: 36 months from the baseline

Definition of "incidence of Diabetes Mellitus"

  • Fasting Glucose ≥126 mg/dL or
  • 75g Oral glucose tolerance test 2 hours after the Blood glucose ≥ 200 mg / dL or
  • HbA1c≥6.5%
36 months from the baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change on HbA1c
Time Frame: 12, 24, 36 months from the baseline
12, 24, 36 months from the baseline
Change on Fasting Glucose
Time Frame: 12, 24, 36 months from the baseline
12, 24, 36 months from the baseline
Change on HOMA2%S
Time Frame: 12, 24, 36 months from the baseline
12, 24, 36 months from the baseline
Change on HOMA2%B
Time Frame: 12, 24, 36 months from the baseline
12, 24, 36 months from the baseline

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

November 1, 2016

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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