Rhee 2019.

Trial name or title	Hospital‐based diabetes prevention study in Korea: A prospective, multicenter, randomised, open‐label, controlled study
Methods	Type of trial: interventional Allocation: randomised Intervention model: parallel Masking: open‐label Primary purpose: prevention
Participants	Condition: IFG, IGT Enrollment: 744 Inclusion criteria: 30 < age < 71; BMI ≥ 23 kg/m2; 75 g OGTT 2 hours after the test blood glucose 140 mg/dL ˜ 199 mg/dL (7.8 mmol/L ˜ 11.1 mmol/L) or fasting blood sugar 110 mg/dL ˜ 125 mg/dL (6.1 mmol/L ˜ 6.9 mmol/L) or HbA1c 5.7% ˜ 6.4% Exclusion criteria: diagnosed with diabetes mellitus except for maternity period or having drugs for diabetes mellitus; type 2 diabetes mellitus; fasting glucose ≥ 126 mg/dL (7.0 mmol/L); 75 g OGTT 2 hours after the blood glucose ≥ 200 mg/dL (11.1 mmol/L); HbA1c ≥ 6.5%; short life expectancy; history of severe cardiovascular disease within the last 6 months (cerebral haemorrhage, stroke, myocardial infarction, angina pectoris, heart failure, etc.); SBP >180 mmHg or DBP >105 mmHg; aortic stenosis; left bundle branch block or third degree AV block; diagnosed and treated for malignant tumours including leukaemia and lymphoma within the last 5 years; abnormal renal function (creatinine ≥ 1.4 mg/dL (123.8 mmol/L) (male) or ≥ 1.3 mg/dL (114.9 mmol/L) (female) or urine protein ≥ 2 +); anaemia (haematocrit < 36% ((male) or >< 33% (female)); cirrhosis or chronic active hepatitis (AST/ALT>３UNL); acute gastrointestinal disease (pancreatitis, infectious intestinal disease); 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; judged to be able to influence the clinical trial by investigator; can not communicate; psychiatric or cognitive impairment that may affect the compliance of the clinical trial; do not agree to the treatment group allocation by random assignment; participate in other studies that may interfere with the clinical trial; lost weight by more than 10% during the past 6 months, excluding weight loss after giving birth; can not have normal walking or exercise; currently pregnant or who are within the last 3 months after giving birth; planning pregnancy during the clinical trial period; have a history of drug and alcohol abuse (acute, chronic) within the last 2 years; not appropriate or unreliable for clinical trials at the discretion of the tester; 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 participant can participate in); other endocrine diseases (e.g. Cushing's syndrome, acromegaly); during treatment, fasting plasma triglyceride > 600 mg/dL (6.8 mmol/L)
Interventions	Intervention: life style modification Comparator (1): conventional management Comparator (2): metformin up to 1000 mg per day Duration of intervention: 36 months
Outcomes	Primary outcomes: cumulative incidence of diabetes mellitus after randomisation Secondary outcomes: change on HbA1c, fasting glucose and HOMA2%B Other outcomes: not stated
Starting date	Study start date: November 2016 Study completion date: November 2020
Contact information	Contact: Jeong‐Taek Woo, email: jtwoomd@khmc.or.kr or Sang Youl Rhee, email: bard95@hanmail.net
Trial identifier	NCT02981121
Notes

2hPG: 2‐hour glucose after an OGTT; AST: aspartate amino transferase; ALT: alanine amino transferase; BMI: body mass index; CABG: coronary artery bypass graft; DBP: diastolic blood pressure; DNA: deoxyribonucleic acid; ETDRS: Early Treatment Diabetic Retinopathy Study; FPG: fasting plasma glucose; GAD: glutamate decarboxylase; GDM: gestational diabetes mellitus; GFR: glomerular filtration rate; HbA1c: glycosylated haemoglobin A1c; IA‐2: insulin antibodies ‐ 2; IFG: impaired fasting glucose; IGR: impaired glucose regulation; IGT: impaired glucose tolerance; NGT: normal glucose tolerance; NYHA: New York Heart Association; OGTT: oral glucose tolerance test; PCI: percutaneous coronary intervention; SBP: systolic blood pressure; SD: standard deviation; TSH: thyroid stimulating hormonE; T2DM type 2 diabetes mellitus.

blood glucose mg/dL converted to mmol/L (via https://www.diabetes.co.uk/blood‐sugar‐converter.html)
 creatinine mg/dL converted to µmol/L (via http://www.endmemo.com/medical/unitconvert/Creatinine.php)
 haemoglobin g/dL converted to mmol/L (via http://unitslab.com/node/7)
 pounds converted to kg (via https://www.convertunits.com/from/pounds/to/kg)
 triglycerides mg/dL converted to mmol/L (via http://www.endmemo.com/medical/unitconvert/Triglycerides.php)