Hospital-based Diabetes Prevention Study in Korea

Jeong-taek Woo

Status and phase: Unknown; Phase 4

Conditions: PreDiabetes

Treatments: Drug: Metformin; Behavioral: Exercise and Diet remedies

Study type: Interventional

Funder types: Other

Identifiers

NCT02981121

KDPS

Details and patient eligibility

About

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

Enrollment: 744 estimated patients

Sex: All

Ages: 31 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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744 participants in 3 patient groups

Conventional Management

No Intervention group

Description:

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.

Life style modification

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise and Diet remedies

Metformin

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin