Hospital-based Diabetes Prevention Study in Korea

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02981121
• Other study ID #: KDPS
• Status: Recruiting
• Phase: Phase 4
• First received: November 28, 2016
• Last updated: July 21, 2017
• Start date: November 2016
• Est. completion date: November 2020

Study information

• Verified date: July 2017
• Source: Kyunghee University Medical Center
• Contact: Jeong-Taek Woo
• Phone: 822-958-8220
• Email: jtwoomd[@]khmc.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 744
• Est. completion date: November 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 70 Years

Eligibility

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)) ? 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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Exercise and Diet remedies

Drug:
• Metformin

Locations

Country	Name	City	State
Korea, Republic of	Kyunghee University Medical Center	Seoul

Sponsors (11)

Lead Sponsor	Collaborator
Jeong-taek Woo	Ajou University School of Medicine, Asan Medical Center, Chonbuk National University Hospital, Korea University Guro Hospital, Kyungpook National University, National Evidence-Based Healthcare Collaborating Agency, Pusan National University Hospital, Samsung Medical Center, Seoul National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of Diabetes Mellitus after randomization	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	Change on HbA1c		12, 24, 36 months from the baseline
Secondary	Change on Fasting Glucose		12, 24, 36 months from the baseline
Secondary	Change on HOMA2%S		12, 24, 36 months from the baseline
Secondary	Change on HOMA2%B		12, 24, 36 months from the baseline