OBJECTIVE: Diabetes mellitus is the most common chronic endocrine disease worldwide. Intensive glycemic control plays an important role in decreasing morbidity and mortality rate of the disease. Preclinical studies have shown that biotin has an essential role in regulating blood glucose and serum lipid metabolism. This study aims to evaluate the effect of biotin on glycemic control and plasma lipids concentrations in type 1diabetic patients. METHODS: This randomized double-blind placebo-controlled clinical trial study was conducted 70 type 1 diabetic patients with an age range 5-25 years old with poorly controlled (glycosylated hemoglobin ≥8%). Subjects were randomly allocated into two groups. In the intervention group biotin (40 microgram/kg) was administered plus daily insulin, while the control group received placebo plus daily insulin regimen for three months. Laboratory tests including glycosylated hemoglobin (HbA1c), fasting blood sugar and plasma lipids were measured at the base and after 3 months. RESULTS: In this study, seventy patients were evaluated, 35 were allocated to each group. There were no statistically significant differences between age, gender, duration of diabetes, BMI and BP between the two groups (p>0.05). HbA1c in the intervention (biotin) group was 9.84±1.80 at base and after 3 months treatment, it declined to 8.88±1.73 (p<0.001). In the control group HbA1c at base was 9.39±1.58, after 3 months it increased to10.11± 1.68. There were statistically significant differences in the mean of HbA1c in both the biotin and the control groups (p<0.001). FBS in the biotin group at base was 275±65.76 mg/dl and after 3 months it had reduced to 226± 41.31 (p<0.001). There were statistically significant differences in the mean of total cholesterol, low density lipoprotein cholesterol and triglyceride between the two groups at the end of 3 months (p<0.05). CONCLUSION: Results of this study showed that biotin administration as an adjuvant in addition to insulin regimen can improve glycemic management and decrease plasma lipids concentrations in poorly controlled type 1 diabetic patients.
RCT Entities:
OBJECTIVE:Diabetes mellitus is the most common chronic endocrine disease worldwide. Intensive glycemic control plays an important role in decreasing morbidity and mortality rate of the disease. Preclinical studies have shown that biotin has an essential role in regulating blood glucose and serum lipid metabolism. This study aims to evaluate the effect of biotin on glycemic control and plasma lipids concentrations in type 1diabeticpatients. METHODS: This randomized double-blind placebo-controlled clinical trial study was conducted 70 type 1 diabeticpatients with an age range 5-25 years old with poorly controlled (glycosylated hemoglobin ≥8%). Subjects were randomly allocated into two groups. In the intervention group biotin (40 microgram/kg) was administered plus daily insulin, while the control group received placebo plus daily insulin regimen for three months. Laboratory tests including glycosylated hemoglobin (HbA1c), fasting blood sugar and plasma lipids were measured at the base and after 3 months. RESULTS: In this study, seventy patients were evaluated, 35 were allocated to each group. There were no statistically significant differences between age, gender, duration of diabetes, BMI and BP between the two groups (p>0.05). HbA1c in the intervention (biotin) group was 9.84±1.80 at base and after 3 months treatment, it declined to 8.88±1.73 (p<0.001). In the control group HbA1c at base was 9.39±1.58, after 3 months it increased to10.11± 1.68. There were statistically significant differences in the mean of HbA1c in both the biotin and the control groups (p<0.001). FBS in the biotin group at base was 275±65.76 mg/dl and after 3 months it had reduced to 226± 41.31 (p<0.001). There were statistically significant differences in the mean of total cholesterol, low density lipoprotein cholesterol and triglyceride between the two groups at the end of 3 months (p<0.05). CONCLUSION: Results of this study showed that biotin administration as an adjuvant in addition to insulin regimen can improve glycemic management and decrease plasma lipids concentrations in poorly controlled type 1 diabeticpatients.
Entities:
Keywords:
Biotin, Serum lipid; HbA1c; Type one diabetes mellitus