newly diagosed type 2 diabetes and prediabetes
Conditions
Interventions
A:short-term calorie restriction therapy
B:short-term insulin intensive therapy
Sponsors
Endocrine and Diabetes Center, Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. volunteered to participate and signed informed consent; 2. male, infertile female, or fertile female who used reliable methods to contraception; 3. aged 18-55 years; 4. newly diagnosed type 2 diabetes or prediabetes: newly diagnosed type 2 diabetes: FPG 7.0 mmol/L-16.7mmol/L, never used any antidiabetic medicines. newly diagnosed prediabetes: FPG<6.9mmol/L, or OGTT 2hPPG<=11.0 mmol/L; 5. HbA1c 5.7%-10%; 6. BMI 18.5-40 kg/m^2; 7. strictly followed the project requirement during the trail.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation period; 2. With history of: Type 1 diabetes mellitus or secondary diabetes; acute or severe chronic complications of diabetes; hyperuricemia; liver disease (except fatty liver) such as liver cirrhosis, HBV and HCV (except carrier), or ALT, AST or TBil above 2 folds of normal upper limit; renal disease or clinically diagnosed renal insufficiency, male SCr =123umol/L; congestive heart failure need medicine treatment; torsade de pointes, ventricular tachycardia or fibrillation, second or third degree A-V block, or prolonging QTc (>500ms); myocardial infarction within 6 months, undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), unstable angina pectoris or apoplexy; acute or chronic pancreatitis; hyperthyroidism; severe chronic infection (tuberculosis); advanced or extensive metastatic malignancy; malnutrition, alcoholism, anorexia nervosa, bulimia; epilepsy, schizophrenia, Alzheimer's disease; AIDS; 3. Occur severe disease during the trial; 4. Potentially unreliable patients, or not suitable for the trial considered by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;FBG;2h PBG;Froctosamin; | — |
Secondary
| Measure | Time frame |
|---|---|
| HOMA-IR;AIRins;Body weight;Waist-to-hip ratio;Blood pressure;Hemorheology;Human body composition analysis;Blood lipid profile; | — |
Countries
China
Contacts
Public ContactChao Liu
Outcome results
None listed