Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
NCT ID: NCT03917784
Last Updated: 2019-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
142 participants
INTERVENTIONAL
2019-02-25
2020-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Curcumin and bioperine
This group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months
Curcumin
Oral supplementation with curcumin 500 mg oral dosing for 3 months
Placebo
This group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months
Starch
Oral supplementation with starch 500 mg oral dosing for 3 months
Interventions
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Curcumin
Oral supplementation with curcumin 500 mg oral dosing for 3 months
Starch
Oral supplementation with starch 500 mg oral dosing for 3 months
Eligibility Criteria
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Inclusion Criteria
* 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 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.).
18 Years
60 Years
ALL
Yes
Sponsors
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Hospital General de México Dr. Eduardo Liceaga
OTHER_GOV
Responsible Party
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César Leonardo González Aguilar
Internal Medicine Resident
Locations
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Hospital General de México Dr. Eduardo Liceaga
Mexico City, Cuauhtémoc, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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American Diabetes Association. 5. Prevention or Delay of Type 2 Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S51-S54. doi: 10.2337/dc18-S005.
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.
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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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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.
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.
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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.
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.
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.
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Abdel Aziz MT, El-Asmar MF, El Nadi EG, Wassef MA, Ahmed HH, Rashed LA, Obaia EM, Sabry D, Hassouna AA, Abdel Aziz AT. The effect of curcumin on insulin release in rat-isolated pancreatic islets. Angiology. 2010 Aug;61(6):557-66. doi: 10.1177/0003319709356424. Epub 2010 Apr 14.
Aziz MT, El-Asmar MF, Rezq AM, Wassef MA, Fouad H, Roshdy NK, Ahmed HH, Rashed LA, Sabry D, Taha FM, Hassouna A. Effects of a novel curcumin derivative on insulin synthesis and secretion in streptozotocin-treated rat pancreatic islets in vitro. Chin Med. 2014 Jan 14;9(1):3. doi: 10.1186/1749-8546-9-3.
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Azuine MA, Bhide SV. Chemopreventive effect of turmeric against stomach and skin tumors induced by chemical carcinogens in Swiss mice. Nutr Cancer. 1992;17(1):77-83. doi: 10.1080/01635589209514174.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DI/18/111/03/067
Identifier Type: -
Identifier Source: org_study_id
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