Diabetes
Conditions
Interventions
Group 1:Intensive lifestyle intervention plus placebo
Group 2:Conventional lifestyle intervention plus pioglitazone
Group 3:Intensive lifestyle intervention plus pioglitazone
control group:Conventional lifestyle intervention plus placebo
Sponsors
People's Hospital, Peking University
Eligibility
Sex/Gender
All
Age
25 Years to 72 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate the trial and sign subject's informed consent form; 2. Clinical diagnosis of PrediabetesIFG: fasting plasma glucose 36.1mmol/L(100mg/dl) and <7.0mmol/L(126mg/dl) and/orIGT: 2h plasma glucose; 3. 7.8mmol/L(140mg/dl) and <11.1mmol/L(200mg/dl) after a 75g oral glucose loadTo meet the World Health Organization criteria of prediabetes, IGT subjects also include those who have both IGT and IFG; 4. Ethnicity: All ethnic groups; 5. Gender: Male and female; 6. Age: Individuals aged 25-70 years old; 7. Body mass index: 22kg/m2 <BMI<35 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Diabetes at baseline: (1)Fasting plasma glucose>7.0 mmol/L(126 mg/dL); (2)2-h plasma glucose >11.1 mmol/L(200 mg/dL) after a 75g oral glucose load; (3)Diabetes diagnosed by physicians with other clinical evidence to support [such as FPG >7.0 mmol/L(126 mg/dL) or diabetes diagnosed by OGTT]; If the patients report diabetes history by themselves without any clinical evidence, and the patients have never used any antidiabetic drugs, then the clinical staff has to perform an OGTT at the site; (4)Receive antidiabetic treatment at any time before (except gestational diabetes); 2. Newly diagnosed coronary artery disease or myocardial infarction, unstable angina in the past 6 months. Hospitalization for the treatment of heart disease or stroke in the past 6 months; 3. New York Heart Association Functional Class >2 or currently treated with a loop diuretic or digitalis preparation; 4. Left bundle branch block on ECG, third degree atrioventricular block on ECG, or other severe arrhythmia; 5. Uncontrolled hypertension: SBP>160 mmHg or DBP>100 mmHg on treatment. Milder degrees of hypertension would prompt referral to primary care provider for treatment (with compatible agent of the trial) but would not exclude; 6. Other severe heart diseases or cerebral vascular diseases not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinic site; 7. Severe pulmonary disease; 8. Recent or significant abdominal surgery; 9. Gastrointestinal disease (pancreatitis, inflammatory bowel disease); 10. Self-reported chronic hepatitis or cirrhosis, or serum AST or ALT elevated by the following criteria: Serum AST level is 2.5 fold elevated above the higher limit; Serum ALT level is 2.5 fold elevated above the higher limit. 11. Any renal disease mentioned as following: (1)Serum creatinine >133 umol/L (1.5 mg/dL); (2)Abnormal urine protein level based on a 24 hour urine collection on one occasion, in the absence of infection or vaginal contamination; (3)Bladder carcinoma history; (4)Gross hematuria or microscopic hematuria (red blood cell>3/hp). 12. Hb600 mg/dL (6.77 mmol/L) on one occasion despite treatment 16. Cancer or being treated with antitumor drugs; 17. Severe extremity dysfunction, which may limit the life style intervention; 18. Active tuberculosis or receiving antituberculosis treatment currently; 19. Major psychiatric disorder or taking psychoactive agents currently. Excessive alcohol intake and/or drug abuse; 20. Taking thiazide diuretics or beta-blockers currently. Taking biacin as a lipid-lowering agents currently. Glucocorticoids other than topical, ophthalmic, and inhaled preparations. Taking weight reducing agent; 21. Allergic to pioglitazone or its component; 22. Currently pregnant or nursing (except for those who will complete nursing in 6 weeks), and pregnancy anticipated during study. Without enough contraceptive method (include sterilization, intrauterine contraceptive device, oral contraceptive agent or condom); 23. Weight loss of >10% in past 6 months for any reason except post-partum weight loss; 24. Another household member is a partic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of diabetes;The metabolism status of normalization of blood gl;The metabolism status of normalization of blood glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of heart diseases and cerebral vascular diseases;All cause mortality;Incidence of hypertension;Lipid profile, fasting insulin level, inflammatory factor (hsCRP), adiponectin;Glucose regulation evaluation after drug washout period;Incidence of metabolic syndrome;Body weight and waistline; | — |
Countries
China
Contacts
Public ContactJi Linong
Outcome results
None listed