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

April 13, 2019 updated by: César Leonardo González Aguilar, Hospital General de México Dr. Eduardo Liceaga
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Cuauhtémoc
      • Mexico City, Cuauhtémoc, Mexico, 06720
        • Recruiting
        • Hospital General de México Dr. Eduardo Liceaga
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
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
Oral supplementation with starch 500 mg oral dosing for 3 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

April 7, 2019

First Submitted That Met QC Criteria

April 13, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 13, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Identified individual participant data for all primary and secondary outcomes measures will be made avaliable

IPD Sharing Time Frame

Data will be avaliable whithin 6 months of study completion

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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