Clinical trial NCT02981121: Hospital-based Diabetes Prevention Study in Korea
Official title: Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PreDiabetes
Keywords: Diabetes Prevention
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: National Evidence-Based Healthcare Collaborating Agency
name: Kyungpook National University Hospital
name: Korea University Guro Hospital
name: Pusan National University Hospital
name: Samsung Medical Center
name: Seoul National University Hospital
name: Asan Medical Center
name: Ajou University School of Medicine
name: Severance Hospital
name: Chonbuk National University Hospital
First posted: 2016-12-02
Enrollment: 744
Sex: ALL
Minimum age (years): 31
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of Diabetes Mellitus after randomization
timeFrame: 36 months from the baseline
Secondary outcomes:
measure: Change on HbA1c
timeFrame: 12, 24, 36 months from the baseline
measure: Change on Fasting Glucose
timeFrame: 12, 24, 36 months from the baseline
measure: Change on HOMA2%S
timeFrame: 12, 24, 36 months from the baseline
measure: Change on HOMA2%B
timeFrame: 12, 24, 36 months from the baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
Study officials:
References:
citation: Rhee SY, Chon S, Ahn KJ, Woo JT; Korean Diabetes Prevention Study Investigators. Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study. Diabetes Metab J. 2019 Feb;43(1):49-58. doi: 10.4093/dmj.2018.0033. Epub 2018 Nov 2.