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

NCT03917784 | Unknown Phase 4 DMC

• 1 other identifier: DI/18/111/03/067
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

Curcumin; Insulin sensitivity; HOMA

Outcome Measures

Primary Outcomes (3)

• HOMA- IR

  (Insulin µU/ml)(Glucose mg/dl)/405.

  3 months

• HOMA- Beta

  (20)(FPI)/(FPG - 3.5)

  3 months

• Matsuda index

  10,000/√\[(basal glucose)(basal insulin)\*(glucose)(insulin)\]

  3 months

Secondary Outcomes (17)

• 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

Study Arms (2)

Curcumin and bioperine

EXPERIMENTAL

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

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

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

Drug: Starch

Interventions

Curcumin DRUG

Oral supplementation with curcumin 500 mg oral dosing for 3 months

Curcumin and bioperine

Starch DRUG

Oral supplementation with starch 500 mg oral dosing for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women with age between 18 and 60 years old.
• With prediabetes diagnosis, according to the American Diabetes Association :
• Fasting serum glucose: 100-125 mg/dL
• Glycosylated hemoglobin (HbA1c): 5.7-6.4%
• Post-prandial glucose: 140-199 mg/dL after an oral dose of 75 g of glucose.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead

Study Sites (1)

Hospital General de México Dr. Eduardo Liceaga

Mexico City, Cuauhtémoc, 06720, Mexico

RECRUITING

Related Publications (25)

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• American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. doi: 10.2337/dc18-S002.

  PMID: 29222373 BACKGROUND

• Alibasic E, Ramic E, Alic A. Prevention of diabetes in family medicine. Mater Sociomed. 2013;25(2):80-2. doi: 10.5455/msm.2013.25.80-82.

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• Ferrannini E. Definition of intervention points in prediabetes. Lancet Diabetes Endocrinol. 2014 Aug;2(8):667-75. doi: 10.1016/S2213-8587(13)70175-X. Epub 2014 Jan 28.

  PMID: 24731662 BACKGROUND

• Rojas-Martinez R, Basto-Abreu A, Aguilar-Salinas CA, Zarate-Rojas E, Villalpando S, Barrientos-Gutierrez T. [Prevalence of previously diagnosed diabetes mellitus in Mexico.]. Salud Publica Mex. 2018 May-Jun;60(3):224-232. doi: 10.21149/8566. Spanish.

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• Defronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Reaven PD, Gastaldelli A; ACT NOW Study. Prediction of diabetes based on baseline metabolic characteristics in individuals at high risk. Diabetes Care. 2013 Nov;36(11):3607-12. doi: 10.2337/dc13-0520. Epub 2013 Sep 23.

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  PMID: 21788628 RESULT

• Lamy A, Tong W, Jung H, Gafni A, Singh K, Tyrwhitt J, Yusuf S, Gerstein HC; ORIGIN Investigators. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications. 2014 Jul-Aug;28(4):553-8. doi: 10.1016/j.jdiacomp.2014.02.012. Epub 2014 Mar 2.

  PMID: 24684774 RESULT

• Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.

  PMID: 3899825 RESULT

• Bonora E, Targher G, Alberiche M, Bonadonna RC, Saggiani F, Zenere MB, Monauni T, Muggeo M. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: studies in subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care. 2000 Jan;23(1):57-63. doi: 10.2337/diacare.23.1.57.

  PMID: 10857969 RESULT

• Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.

  PMID: 10480510 RESULT

• Chuengsamarn S, Rattanamongkolgul S, Luechapudiporn R, Phisalaphong C, Jirawatnotai S. Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2121-7. doi: 10.2337/dc12-0116. Epub 2012 Jul 6.

  PMID: 22773702 RESULT

• Na LX, Li Y, Pan HZ, Zhou XL, Sun DJ, Meng M, Li XX, Sun CH. Curcuminoids exert glucose-lowering effect in type 2 diabetes by decreasing serum free fatty acids: a double-blind, placebo-controlled trial. Mol Nutr Food Res. 2013 Sep;57(9):1569-77. doi: 10.1002/mnfr.201200131. Epub 2012 Aug 29.

  PMID: 22930403 RESULT

• Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014 Feb;25(2):144-50. doi: 10.1016/j.jnutbio.2013.09.013. Epub 2013 Nov 6.

  PMID: 24445038 RESULT

• Zhao SG, Li Q, Liu ZX, Wang JJ, Wang XX, Qin M, Wen QS. Curcumin attenuates insulin resistance in hepatocytes by inducing Nrf2 nuclear translocation. Hepatogastroenterology. 2011 Nov-Dec;58(112):2106-11. doi: 10.5754/hge11219.

  PMID: 22024084 RESULT

• Kang C, Kim E. Synergistic effect of curcumin and insulin on muscle cell glucose metabolism. Food Chem Toxicol. 2010 Aug-Sep;48(8-9):2366-73. doi: 10.1016/j.fct.2010.05.073. Epub 2010 Jun 1.

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• Shao W, Yu Z, Chiang Y, Yang Y, Chai T, Foltz W, Lu H, Fantus IG, Jin T. Curcumin prevents high fat diet induced insulin resistance and obesity via attenuating lipogenesis in liver and inflammatory pathway in adipocytes. PLoS One. 2012;7(1):e28784. doi: 10.1371/journal.pone.0028784. Epub 2012 Jan 9.

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MeSH Terms

Conditions

Prediabetic State; Insulin Resistance

Interventions

Curcumin; Starch

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Central Study Contacts

César L González

CONTACT

01 993 117 1322; celsbca_21033@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Resident

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

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 17, 2019
• Study Start: February 25, 2019
• Primary Completion: November 30, 2019
• Study Completion: February 28, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be avaliable whithin 6 months of study completion

Locations

ME (1)