Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes

Study Overview
=================
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.

Official Title
-----------------
Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes

Conditions
-----------------
PreDiabetes

Intervention / Treatment
-----------------
* Drug: Curcumin
* Drug: Starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with age between 18 and 60 years old. With prediabetes diagnosis, according to the American Diabetes Association : Fasting serum glucose: 100-125 mg/dL Glycosylated hemoglobin (HbA1c): 5.7-6.4% 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.).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled clinical trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin and bioperine<br>This group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months | Drug: Curcumin<br>* Oral supplementation with curcumin 500 mg oral dosing for 3 months<br>|
| Placebo Comparator: Placebo<br>This group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months | Drug: Starch<br>* Oral supplementation with starch 500 mg oral dosing for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA- IR | (Insulin µU/ml)(Glucose mg/dl)/405. | 3 months | 
| HOMA- Beta | (20)(FPI)/(FPG - 3.5) | 3 months | 
| Matsuda index | 10,000/√[(basal glucose)(basal insulin)*(glucose)(insulin)] | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | weight in kilograms | 6 weeks and 12 weeks | 
| height | height in centimetres | 6 weeks and 12 weeks | 
| waist circumference | waist circumference in centimetres | 6 weeks and 12 weeks | 
| hip circumference. | hip circumference in centimetres | 6 weeks and 12 weeks | 
| insulin | insulin in µU/ml | 6 weeks and 12 weeks | 
| triglycerides | triglycerides in mg/dl | 6 weeks and 12 weeks | 
| cholesterol | cholesterol in mg/dl | 6 weeks and 12 weeks | 
| HDL cholesterol | HDL cholesterol in mg/dl | 6 weeks and 12 weeks | 
| LDL cholesterol | LDL cholesterol in mg/dl | 6 weeks and 12 weeks | 
| uric acid | uric acid in mg/dl | 6 weeks and 12 weeks | 
| creatinine | creatinine in mg/dl | 6 weeks and 12 weeks | 
| urea | urea in mg/dl | 6 weeks and 12 weeks | 
| alanine amino transferase | alanine amino transferase in U/L | 6 weeks and 12 weeks | 
| alkaline phosphatase | alkaline phosphatase in U/L | 6 weeks and 12 weeks | 
| lactic dehydrogenase | lactic dehydrogenase in U/L | 6 weeks and 12 weeks | 
| glycosylated hemoglobin | glycosylated hemoglobin in percentage | 6 weeks and 12 weeks | 
| total bilirubin | total bilirubin in mg/dl | 6 weeks and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Curcumin, Insulin sensitivity, HOMA