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

Hospital General de México Dr. Eduardo Liceaga

Status and phase: Unknown; Phase 4

Conditions: PreDiabetes

Treatments: Drug: Starch; Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03917784

DI/18/111/03/067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 2 patient groups, including a placebo group

Curcumin and bioperine

Experimental group

Description:

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

Treatment:

Drug: Curcumin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Starch