Clinical trial NCT03917784: Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
Official title: Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PreDiabetes
Keywords: Curcumin
Insulin sensitivity
HOMA
Lead sponsor: Hospital General de México Dr. Eduardo Liceaga
Sponsor class: OTHER_GOV
First posted: 2019-04-17
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled clinical trial.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: HOMA- IR
timeFrame: 3 months
measure: HOMA- Beta
timeFrame: 3 months
measure: Matsuda index
timeFrame: 3 months
Secondary outcomes:
measure: weight
timeFrame: 6 weeks and 12 weeks
measure: height
timeFrame: 6 weeks and 12 weeks
measure: waist circumference
timeFrame: 6 weeks and 12 weeks
measure: hip circumference.
timeFrame: 6 weeks and 12 weeks
measure: insulin
timeFrame: 6 weeks and 12 weeks
measure: triglycerides
timeFrame: 6 weeks and 12 weeks
measure: cholesterol
timeFrame: 6 weeks and 12 weeks
measure: HDL cholesterol
timeFrame: 6 weeks and 12 weeks
measure: LDL cholesterol
timeFrame: 6 weeks and 12 weeks
measure: uric acid
timeFrame: 6 weeks and 12 weeks
measure: creatinine
timeFrame: 6 weeks and 12 weeks
measure: urea
timeFrame: 6 weeks and 12 weeks
measure: alanine amino transferase
timeFrame: 6 weeks and 12 weeks
measure: alkaline phosphatase
timeFrame: 6 weeks and 12 weeks
measure: lactic dehydrogenase
timeFrame: 6 weeks and 12 weeks
measure: glycosylated hemoglobin
timeFrame: 6 weeks and 12 weeks
measure: total bilirubin
timeFrame: 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de México Dr. Eduardo Liceaga
state: Cuauhtémoc
Study officials:
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