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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03917784
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
César Leonardo González Aguilar, Hospital General de México Dr. Eduardo Liceaga

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : February 25, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Prediabetes

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

Primary Outcome Measures :
  1. HOMA- IR [ Time Frame: 3 months ]
    (Insulin µU/ml)(Glucose mg/dl)/405.

  2. HOMA- Beta [ Time Frame: 3 months ]
    (20)(FPI)/(FPG - 3.5)

  3. Matsuda index [ Time Frame: 3 months ]
    10,000/√[(basal glucose)(basal insulin)*(glucose)(insulin)]

Secondary Outcome Measures :
  1. weight [ Time Frame: 6 weeks and 12 weeks ]
    weight in kilograms

  2. height [ Time Frame: 6 weeks and 12 weeks ]
    height in centimetres

  3. waist circumference [ Time Frame: 6 weeks and 12 weeks ]
    waist circumference in centimetres

  4. hip circumference. [ Time Frame: 6 weeks and 12 weeks ]
    hip circumference in centimetres

  5. insulin [ Time Frame: 6 weeks and 12 weeks ]
    insulin in µU/ml

  6. triglycerides [ Time Frame: 6 weeks and 12 weeks ]
    triglycerides in mg/dl

  7. cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    cholesterol in mg/dl

  8. HDL cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    HDL cholesterol in mg/dl

  9. LDL cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    LDL cholesterol in mg/dl

  10. uric acid [ Time Frame: 6 weeks and 12 weeks ]
    uric acid in mg/dl

  11. creatinine [ Time Frame: 6 weeks and 12 weeks ]
    creatinine in mg/dl

  12. urea [ Time Frame: 6 weeks and 12 weeks ]
    urea in mg/dl

  13. alanine amino transferase [ Time Frame: 6 weeks and 12 weeks ]
    alanine amino transferase in U/L

  14. alkaline phosphatase [ Time Frame: 6 weeks and 12 weeks ]
    alkaline phosphatase in U/L

  15. lactic dehydrogenase [ Time Frame: 6 weeks and 12 weeks ]
    lactic dehydrogenase in U/L

  16. glycosylated hemoglobin [ Time Frame: 6 weeks and 12 weeks ]
    glycosylated hemoglobin in percentage

  17. total bilirubin [ Time Frame: 6 weeks and 12 weeks ]
    total bilirubin in mg/dl

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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 :

    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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03917784

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Contact: César L González 01 993 117 1322

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Hospital General de México Dr. Eduardo Liceaga Recruiting
Mexico City, Cuauhtémoc, Mexico, 06720
Contact: Ernesto Roldan    2789-2000 ext 1164   
Sponsors and Collaborators
Hospital General de México Dr. Eduardo Liceaga
  Study Documents (Full-Text)

Documents provided by César Leonardo González Aguilar, Hospital General de México Dr. Eduardo Liceaga:
Publications of Results:

Other Publications:
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Responsible Party: César Leonardo González Aguilar, Internal Medicine Resident, Hospital General de México Dr. Eduardo Liceaga Identifier: NCT03917784    
Other Study ID Numbers: DI/18/111/03/067
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Identified individual participant data for all primary and secondary outcomes measures will be made avaliable
Supporting Materials: Study Protocol
Time Frame: Data will be avaliable whithin 6 months of study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by César Leonardo González Aguilar, Hospital General de México Dr. Eduardo Liceaga:
Insulin sensitivity
Additional relevant MeSH terms:
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Insulin Resistance
Prediabetic State
Glucose Intolerance
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action