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Table 1 Primary and secondary outcomes of the trial

From: Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial

Purpose

 

Measurements

Primary outcome

 

The absolute value of fasting plasma glucose (FPG) compared with baseline after 16 weeks of treatment

Secondary outcomes

1

The proportion of patients who meet following blood glucose response: (1) HbA1c < 7.0%; (2) HbA1c < 7.0%, without severe hypoglycemia; (3) HbA1c < 7.0%, without diagnosed hypoglycemia; (4) HbA1c < 6.0%; (5) HbA1c < 6.0%, without severe hypoglycemia; (6) HbA1c < 6.0%, without diagnosed hypoglycemia; (7) FPG < 110 mg/dL (6.1 mmol/L); (8) FPG < 130 mg/dL (7.2 mmol/L)

2

Changes compared with baseline: (1) 2-h postprandial glucose (2-h PPG): (2) glycosylated hemoglobin (HbA1c); (3) 2 h PPG < 140 mg/dL (7.8 mmol/L); (4) 2-h PPG <180 mg/dL (10.0 mmol/L); (5) HbA1c reduced by 0.5%; (6) blood pressure (BP); (7) lipid changes: total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG); (8) Body weight and Body Mass Index (BMI); (9) HOMA Index, insulin early phase and late-phase secretion index; (10) intestinal hormones (GLP-1, glucagon); (11) intestinal flora

Safety purpose

 

Laboratory data: electrocardiograph (ECG); pulse and blood pressure (BP); weight and physical examination.

  1. HbA1c glycosylated hemoglobin