This study evaluates the effects of oral supplementation with curcumin on the insulin sensitivity in subjects with prediabetes. The half of participants will receive curcumin and bioperine in combination, while the other half receive placebo.
The therapeutic strategies for prediabetes to this day are based on the change of habits, mainly food and exercise plans. It has been advice, in specific circumstances, to grant a pharmacological regimen. Curcumin or Curcuma Longa ((1E,6E)21,7-bis(4-hydroxy-3-methoxyphenyl)-1,6- heptadiene-3,5-dione), is the main ingredient of the Hindu condiment, Turmeric, which is obtained from the Rhizome plant. In new studies, it has been documented that the oral consumption of curcumin (Curcuma longa) in pre-diabetic and diabetic patients has a positive effect as an antidiabetic agent thanks to its anti-inflammatory, antioxidant, antithrombotic, cardio and neuroprotective effects. In animal models, it has been shown that oral curcumin consumption is capable of increasing insulin sensitivity in liver, muscle and adipose tissue, increases glucose uptake in muscle and insulin secretion, which is reflected in the reduction of hyperglycemia, glycosylated hemoglobin, decrease of the homeostatic model assessment of insulin resistance (HOMA-IR) and decrease of serum lipids. Curcumin has been included in the oriental diet since ancient times and is used in traditional medicine, which is why it is considered safe, since its consumption is approved by the FDA (Federal Drugs Administration). A 12g per day dose has shown no side effects in humans. Therefore, it is proposed that the consumption of curcumin in pre-diabetic patients can improve glucose tolerance and decrease insulin resistance parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
142
Hospital General de México Dr. Eduardo Liceaga
Mexico City, Cuauhtémoc, Mexico
RECRUITINGHOMA- IR
(Insulin µU/ml)(Glucose mg/dl)/405.
Time frame: 3 months
HOMA- Beta
(20)(FPI)/(FPG - 3.5)
Time frame: 3 months
Matsuda index
10,000/√\[(basal glucose)(basal insulin)\*(glucose)(insulin)\]
Time frame: 3 months
weight
weight in kilograms
Time frame: 6 weeks and 12 weeks
height
height in centimetres
Time frame: 6 weeks and 12 weeks
waist circumference
waist circumference in centimetres
Time frame: 6 weeks and 12 weeks
hip circumference.
hip circumference in centimetres
Time frame: 6 weeks and 12 weeks
insulin
insulin in µU/ml
Time frame: 6 weeks and 12 weeks
triglycerides
triglycerides in mg/dl
Time frame: 6 weeks and 12 weeks
cholesterol
cholesterol in mg/dl
Time frame: 6 weeks and 12 weeks
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HDL cholesterol
HDL cholesterol in mg/dl
Time frame: 6 weeks and 12 weeks
LDL cholesterol
LDL cholesterol in mg/dl
Time frame: 6 weeks and 12 weeks
uric acid
uric acid in mg/dl
Time frame: 6 weeks and 12 weeks
creatinine
creatinine in mg/dl
Time frame: 6 weeks and 12 weeks
urea
urea in mg/dl
Time frame: 6 weeks and 12 weeks
alanine amino transferase
alanine amino transferase in U/L
Time frame: 6 weeks and 12 weeks
alkaline phosphatase
alkaline phosphatase in U/L
Time frame: 6 weeks and 12 weeks
lactic dehydrogenase
lactic dehydrogenase in U/L
Time frame: 6 weeks and 12 weeks
glycosylated hemoglobin
glycosylated hemoglobin in percentage
Time frame: 6 weeks and 12 weeks
total bilirubin
total bilirubin in mg/dl
Time frame: 6 weeks and 12 weeks