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

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

Sponsors

Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga

Source 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.

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.

Overall Status Recruiting
Start Date 2019-02-25
Completion Date 2020-02-28
Primary Completion Date 2019-11-30
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
HOMA- IR 3 months
HOMA- Beta 3 months
Matsuda index 3 months
Secondary Outcome
Measure Time Frame
weight 6 weeks and 12 weeks
height 6 weeks and 12 weeks
waist circumference 6 weeks and 12 weeks
hip circumference. 6 weeks and 12 weeks
insulin 6 weeks and 12 weeks
triglycerides 6 weeks and 12 weeks
cholesterol 6 weeks and 12 weeks
HDL cholesterol 6 weeks and 12 weeks
LDL cholesterol 6 weeks and 12 weeks
uric acid 6 weeks and 12 weeks
creatinine 6 weeks and 12 weeks
urea 6 weeks and 12 weeks
alanine amino transferase 6 weeks and 12 weeks
alkaline phosphatase 6 weeks and 12 weeks
lactic dehydrogenase 6 weeks and 12 weeks
glycosylated hemoglobin 6 weeks and 12 weeks
total bilirubin 6 weeks and 12 weeks
Enrollment 142
Condition
Intervention

Intervention Type: Drug

Intervention Name: Curcumin

Description: Oral supplementation with curcumin 500 mg oral dosing for 3 months

Arm Group Label: Curcumin and bioperine

Intervention Type: Drug

Intervention Name: Starch

Description: Oral supplementation with starch 500 mg oral dosing for 3 months

Arm Group Label: Placebo

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.).

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: César L González

Phone: 01 993 117 1322

Email: [email protected]

Location
Facility: Status: Contact: Hospital General de México Dr. Eduardo Liceaga Ernesto Roldan 2789-2000 1164 [email protected]
Location Countries

Mexico

Verification Date

2019-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital General de México Dr. Eduardo Liceaga

Investigator Full Name: César Leonardo González Aguilar

Investigator Title: Internal Medicine Resident

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Curcumin and bioperine

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized, double-blind, placebo-controlled clinical trial.

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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