The effects of the fruit on blood glucose levels were assessed in patients
with diabetes (26). Nineteen subjects were enrolled in the study,
including 14 patients with type I or type II diabetes mellitus, and five
healthy volunteers. The preparation used in this investigation was a protein
isolated from the crude drug and termed “vegetable insulin”. The
protein extract was suspended in sterile water and administered subcutaneously
at a concentration of 1.8 mg of protein per 40-unit dose. Nine of
the diabetic patients received 10 units of the formulation if their fasting
blood sugar was less than 180 mg/dl; 20 units when it was 180–250 mg/dl;
and 30 units when it was > 250 mg/dl. Five patients with diabetes and five
healthy volunteers received a placebo (sterile water). The primary endpoint
was a decrease in fasting blood glucose, which was measured over
12 hours after administration. The results showed a mean decrease in serum
glucose levels for the diabetic patients receiving treatment as early as
30 minutes after administration, a 21.5% decrease from mean baseline of
295 mg/dl. After 4 hours, a maximum decrease of 49.2% in serum glucose
was observed, and at 12 hours a 28% drop persisted. In contrast, patients
administered the placebo had a 5% decrease in serum glucose over the
study period. The patients with diabetes who received treatment had substantially
reduced mean baseline serum glucose concentrations, 295 mg/dl
versus a concentration in the placebo group of 210 mg/dl. No blinding,
randomization or statistical analyses were performed (26).
The effects of the fruit on blood glucose levels were assessed in patientswith diabetes (26). Nineteen subjects were enrolled in the study,including 14 patients with type I or type II diabetes mellitus, and fivehealthy volunteers. The preparation used in this investigation was a proteinisolated from the crude drug and termed “vegetable insulin”. Theprotein extract was suspended in sterile water and administered subcutaneouslyat a concentration of 1.8 mg of protein per 40-unit dose. Nine ofthe diabetic patients received 10 units of the formulation if their fastingblood sugar was less than 180 mg/dl; 20 units when it was 180–250 mg/dl;and 30 units when it was > 250 mg/dl. Five patients with diabetes and fivehealthy volunteers received a placebo (sterile water). The primary endpointwas a decrease in fasting blood glucose, which was measured over12 hours after administration. The results showed a mean decrease in serumglucose levels for the diabetic patients receiving treatment as early as30 minutes after administration, a 21.5% decrease from mean baseline of295 mg/dl. After 4 hours, a maximum decrease of 49.2% in serum glucosewas observed, and at 12 hours a 28% drop persisted. In contrast, patientsadministered the placebo had a 5% decrease in serum glucose over thestudy period. The patients with diabetes who received treatment had substantiallyreduced mean baseline serum glucose concentrations, 295 mg/dlversus a concentration in the placebo group of 210 mg/dl. No blinding,randomization or statistical analyses were performed (26).
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