PreDiabetes
Conditions
Keywords
Curcumin, Insulin sensitivity, HOMA
Brief summary
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.
Detailed description
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.
Interventions
DRUGCurcumin
Oral supplementation with curcumin 500 mg oral dosing for 3 months
DRUGStarch
Oral supplementation with starch 500 mg oral dosing for 3 months
Sponsors
Hospital General de México Dr. Eduardo Liceaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women with age between 18 and 60 years old. * With prediabetes diagnosis, according to the American Diabetes Association : 1. Fasting serum glucose: 100-125 mg/dL 2. Glycosylated hemoglobin (HbA1c): 5.7-6.4% 3. Post-prandial glucose: 140-199 mg/dL after an oral dose of 75 g of glucose.
Exclusion criteria
* Subjects with any type of diabetes. * Subjects with body mass index \> 35 kg/m2 * Pregnant Women. * Volunteers who ingest drugs that alter blood glucose levels, antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, fibrates, statins. * Subjects with serum creatinine \> 2 mg/dL or in renal replacement therapy. * Subjects that normally consume food supplements. * Subjects with acute infections or with chronical diseases (cancer, rheumatoid arthritis, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA- IR | 3 months | (Insulin µU/ml)(Glucose mg/dl)/405. |
| HOMA- Beta | 3 months | (20)(FPI)/(FPG - 3.5) |
| Matsuda index | 3 months | 10,000/√\[(basal glucose)(basal insulin)\*(glucose)(insulin)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weight | 6 weeks and 12 weeks | weight in kilograms |
| height | 6 weeks and 12 weeks | height in centimetres |
| waist circumference | 6 weeks and 12 weeks | waist circumference in centimetres |
| hip circumference. | 6 weeks and 12 weeks | hip circumference in centimetres |
| insulin | 6 weeks and 12 weeks | insulin in µU/ml |
| LDL cholesterol | 6 weeks and 12 weeks | LDL cholesterol in mg/dl |
| uric acid | 6 weeks and 12 weeks | uric acid in mg/dl |
| triglycerides | 6 weeks and 12 weeks | triglycerides in mg/dl |
| urea | 6 weeks and 12 weeks | urea in mg/dl |
| alanine amino transferase | 6 weeks and 12 weeks | alanine amino transferase in U/L |
| alkaline phosphatase | 6 weeks and 12 weeks | alkaline phosphatase in U/L |
| lactic dehydrogenase | 6 weeks and 12 weeks | lactic dehydrogenase in U/L |
| glycosylated hemoglobin | 6 weeks and 12 weeks | glycosylated hemoglobin in percentage |
| total bilirubin | 6 weeks and 12 weeks | total bilirubin in mg/dl |
| creatinine | 6 weeks and 12 weeks | creatinine in mg/dl |
| cholesterol | 6 weeks and 12 weeks | cholesterol in mg/dl |
| HDL cholesterol | 6 weeks and 12 weeks | HDL cholesterol in mg/dl |
Countries
Mexico
Contacts
Primary ContactCésar L González
Outcome results
None listed