Last updated: October 8, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
4
Condition
Diabetes Prevention
Diabetes Mellitus, Type 2
Diabetes And Hypertension
Treatment
N/AClinical Study ID
NCT05084079
2021526
Ages 20-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Newly diagnosed type 2 diabetes (1999 World Health Organization standard);
- Type 2 diabetic patients who have never received any hypoglycemic therapy (includingoral hypoglycemic agents, Chinese medicine , and insulin);
- Body mass index (BMI) between 20-35 kg/m2;
- Fasting plasma glucose (FPG) levels between 7.0 -16.7 mmol/L, glycated haemoglobin >7.0%;
- Willing to receive CSII intensive treatment during hospitalization and monitoringblood glucose 8 times per day.
Exclusion
Exclusion Criteria:
- Type 1 diabetes or special type of diabetes;
- Acute complications of diabetes: ketoacidosis, hyperosmolar coma, lactic acidosis,etc.;
- Severe macrovascular complications: acute cerebral vascular accidents, acute coronarysyndromes, peripheral arterial disease requiring vascular intervention or amputees forhospitalization occur within 12 months before selection;
- Severe microvascular complications: proliferative phase retinopathy; urinary albuminexcretion rate(AER)> 300 mg/g or urinary protein Positive, quantitative> 0.5 g/d;uncontrolled painful diabetic neuropathy and significant diabetic autonomicneuropathy;
- Obvious liver and kidney dysfunction: alanine aminotransferase ≥ 2.5 times the upperlimit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serumcreatinine greater than 150 umol/L or creatinine clearance less than 50 mL/min;
- Significant increase in blood pressure: blood pressure continued to be higher than 180/110 mmHg;
- Significant anemia: hemoglobin <100g /L may require regular blood transfusions;
- Use of drugs that may affect blood glucose during 12 weeks, such as oral/intravenouscorticosteroids, growth hormone, estrogen/progestogen, high-dose diuretics,antipsychotics, etc. Low-dose diuretics for antihypertensive purposes (hydrochlorothiazide <25 mg/d, indapamide ≤ 1.5 mg/d), and physiological quantities ofthyroid hormones used for replacement therapy are not limited to this;
- Effects associated with other underlying diseases influenced the observation of bloodglucose, such as systemic infection or severe comorbidity, malignancy or chronicdiarrhea, uncontrolled endocrine gland function abnormalities, chronic cardiacinsufficiency (grade III and above), psychosis, or pregnant;
- The patients does not cooperate, or the investigator judges that it may be difficultto complete the study.
Study Design
Total Participants: 56
Study Start date:
November 01, 2021
Estimated Completion Date:
October 31, 2022
Study Description
Connect with a study center
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
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