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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03917784
• Other study ID #: DI/18/111/03/067
• Status: Recruiting
• Phase: Phase 4
• Start date: February 25, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2019
• Source: Hospital General de México Dr. Eduardo Liceaga
• Contact: César L González
• Phone: 01 993 117 1322
• Email: celsbca_21033[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: February 28, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Glucose Intolerance
• Hypersensitivity
• Insulin Resistance
• PreDiabetes
• Prediabetic State

Intervention

Drug:
• Curcumin
Oral supplementation with curcumin 500 mg oral dosing for 3 months
• Starch
Oral supplementation with starch 500 mg oral dosing for 3 months

Locations

Country	Name	City	State
Mexico	Hospital General de México Dr. Eduardo Liceaga	Mexico City	Cuauhtémoc

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de México Dr. Eduardo Liceaga

Country where clinical trial is conducted

Mexico, 

References & Publications (25)

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: 10.1177/000331970935 — View Citation

Abdul-Ghani MA, Abdul-Ghani T, Stern MP, Karavic J, Tuomi T, Bo I, Defronzo RA, Groop L. Two-step approach for the prediction of future type 2 diabetes risk. Diabetes Care. 2011 Sep;34(9):2108-12. doi: 10.2337/dc10-2201. Epub 2011 Jul 25. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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 gluc — View Citation

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. — View Citation

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.j — View Citation

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 — View Citation

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. — View Citation

Ganjali S, Sahebkar A, Mahdipour E, Jamialahmadi K, Torabi S, Akhlaghi S, Ferns G, Parizadeh SM, Ghayour-Mobarhan M. Investigation of the effects of curcumin on serum cytokines in obese individuals: a randomized controlled trial. ScientificWorldJournal. 2 — View Citation

Hu GX, Lin H, Lian QQ, Zhou SH, Guo J, Zhou HY, Chu Y, Ge RS. Curcumin as a potent and selective inhibitor of 11ß-hydroxysteroid dehydrogenase 1: improving lipid profiles in high-fat-diet-treated rats. PLoS One. 2013;8(3):e49976. doi: 10.1371/journal.pone — View Citation

Huang MT, Lou YR, Ma W, Newmark HL, Reuhl KR, Conney AH. Inhibitory effects of dietary curcumin on forestomach, duodenal, and colon carcinogenesis in mice. Cancer Res. 1994 Nov 15;54(22):5841-7. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Mohammadi A, Sahebkar A, Iranshahi M, Amini M, Khojasteh R, Ghayour-Mobarhan M, Ferns GA. Effects of supplementation with curcuminoids on dyslipidemia in obese patients: a randomized crossover trial. Phytother Res. 2013 Mar;27(3):374-9. doi: 10.1002/ptr.4 — View Citation

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: 10.1 — View Citation

Nagabhushan M, Bhide SV. Curcumin as an inhibitor of cancer. J Am Coll Nutr. 1992 Apr;11(2):192-8. — View Citation

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

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: 1 — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA- IR	(Insulin µU/ml)(Glucose mg/dl)/405.	3 months
Primary	HOMA- Beta	(20)(FPI)/(FPG - 3.5)	3 months
Primary	Matsuda index	10,000/v[(basal glucose)(basal insulin)*(glucose)(insulin)]	3 months
Secondary	weight	weight in kilograms	6 weeks and 12 weeks
Secondary	height	height in centimetres	6 weeks and 12 weeks
Secondary	waist circumference	waist circumference in centimetres	6 weeks and 12 weeks
Secondary	hip circumference.	hip circumference in centimetres	6 weeks and 12 weeks
Secondary	insulin	insulin in µU/ml	6 weeks and 12 weeks
Secondary	triglycerides	triglycerides in mg/dl	6 weeks and 12 weeks
Secondary	cholesterol	cholesterol in mg/dl	6 weeks and 12 weeks
Secondary	HDL cholesterol	HDL cholesterol in mg/dl	6 weeks and 12 weeks
Secondary	LDL cholesterol	LDL cholesterol in mg/dl	6 weeks and 12 weeks
Secondary	uric acid	uric acid in mg/dl	6 weeks and 12 weeks
Secondary	creatinine	creatinine in mg/dl	6 weeks and 12 weeks
Secondary	urea	urea in mg/dl	6 weeks and 12 weeks
Secondary	alanine amino transferase	alanine amino transferase in U/L	6 weeks and 12 weeks
Secondary	alkaline phosphatase	alkaline phosphatase in U/L	6 weeks and 12 weeks
Secondary	lactic dehydrogenase	lactic dehydrogenase in U/L	6 weeks and 12 weeks
Secondary	glycosylated hemoglobin	glycosylated hemoglobin in percentage	6 weeks and 12 weeks
Secondary	total bilirubin	total bilirubin in mg/dl	6 weeks and 12 weeks