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

Sponsor

Hospital General de México Dr. Eduardo Liceaga (Other)

Overall Status

Unknown status

CT.gov ID

NCT03917784

Collaborator

(none)

142

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PreDiabetes	Drug: Curcumin Drug: Starch	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlled clinical trial.Randomized, double-blind, placebo-controlled clinical trial.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 25, 2019

Anticipated Primary Completion Date :

Nov 30, 2019

Anticipated Study Completion Date :

Feb 28, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Curcumin and bioperine

This group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months

Drug: Curcumin

Oral supplementation with curcumin 500 mg oral dosing for 3 months

Placebo Comparator: Placebo

This group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months

Drug: Starch

Oral supplementation with starch 500 mg oral dosing for 3 months

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
triglycerides [6 weeks and 12 weeks]
triglycerides 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
LDL cholesterol [6 weeks and 12 weeks]
LDL cholesterol in mg/dl
uric acid [6 weeks and 12 weeks]
uric acid in mg/dl
creatinine [6 weeks and 12 weeks]
creatinine 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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 :

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.).