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出境医 / 临床实验 / 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

Study Description
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.

Condition or disease Intervention/treatment Phase
PreDiabetes Drug: Curcumin Drug: Starch Phase 4

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : February 28, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Curcumin and bioperine
This group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months
 Drug: Curcumin
Oral supplementation with curcumin 500 mg oral dosing for 3 months
Placebo Comparator: Placebo
This group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months
 Drug: Starch
Oral supplementation with starch 500 mg oral dosing for 3 months
Outcome Measures
Primary Outcome Measures :
  1. HOMA- IR [ Time Frame: 3 months ]
    (Insulin µU/ml)(Glucose mg/dl)/405.

  2. HOMA- Beta [ Time Frame: 3 months ]
    (20)(FPI)/(FPG - 3.5)

  3. Matsuda index [ Time Frame: 3 months ]
    10,000/√[(basal glucose)(basal insulin)*(glucose)(insulin)]


Secondary Outcome Measures :
  1. weight [ Time Frame: 6 weeks and 12 weeks ]
    weight in kilograms

  2. height [ Time Frame: 6 weeks and 12 weeks ]
    height in centimetres

  3. waist circumference [ Time Frame: 6 weeks and 12 weeks ]
    waist circumference in centimetres

  4. hip circumference. [ Time Frame: 6 weeks and 12 weeks ]
    hip circumference in centimetres

  5. insulin [ Time Frame: 6 weeks and 12 weeks ]
    insulin in µU/ml

  6. triglycerides [ Time Frame: 6 weeks and 12 weeks ]
    triglycerides in mg/dl

  7. cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    cholesterol in mg/dl

  8. HDL cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    HDL cholesterol in mg/dl

  9. LDL cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    LDL cholesterol in mg/dl

  10. uric acid [ Time Frame: 6 weeks and 12 weeks ]
    uric acid in mg/dl

  11. creatinine [ Time Frame: 6 weeks and 12 weeks ]
    creatinine in mg/dl

  12. urea [ Time Frame: 6 weeks and 12 weeks ]
    urea in mg/dl

  13. alanine amino transferase [ Time Frame: 6 weeks and 12 weeks ]
    alanine amino transferase in U/L

  14. alkaline phosphatase [ Time Frame: 6 weeks and 12 weeks ]
    alkaline phosphatase in U/L

  15. lactic dehydrogenase [ Time Frame: 6 weeks and 12 weeks ]
    lactic dehydrogenase in U/L

  16. glycosylated hemoglobin [ Time Frame: 6 weeks and 12 weeks ]
    glycosylated hemoglobin in percentage

  17. total bilirubin [ Time Frame: 6 weeks and 12 weeks ]
    total bilirubin in mg/dl


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: César L González 01 993 117 1322 celsbca_21033@hotmail.com

Locations
Layout table for location information
Mexico
Hospital General de México Dr. Eduardo Liceaga Recruiting
Mexico City, Cuauhtémoc, Mexico, 06720
Contact: Ernesto Roldan    2789-2000 ext 1164    ernest.roldan@usa.net   
Sponsors and Collaborators
Hospital General de México Dr. Eduardo Liceaga
Tracking Information
First Submitted Date  ICMJE April 7, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE February 25, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
  • HOMA- IR [ Time Frame: 3 months ]
    (Insulin µU/ml)(Glucose mg/dl)/405.
  • HOMA- Beta [ Time Frame: 3 months ]
    (20)(FPI)/(FPG - 3.5)
  • Matsuda index [ Time Frame: 3 months ]
    10,000/√[(basal glucose)(basal insulin)*(glucose)(insulin)]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
  • weight [ Time Frame: 6 weeks and 12 weeks ]
    weight in kilograms
  • height [ Time Frame: 6 weeks and 12 weeks ]
    height in centimetres
  • waist circumference [ Time Frame: 6 weeks and 12 weeks ]
    waist circumference in centimetres
  • hip circumference. [ Time Frame: 6 weeks and 12 weeks ]
    hip circumference in centimetres
  • insulin [ Time Frame: 6 weeks and 12 weeks ]
    insulin in µU/ml
  • triglycerides [ Time Frame: 6 weeks and 12 weeks ]
    triglycerides in mg/dl
  • cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    cholesterol in mg/dl
  • HDL cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    HDL cholesterol in mg/dl
  • LDL cholesterol [ Time Frame: 6 weeks and 12 weeks ]
    LDL cholesterol in mg/dl
  • uric acid [ Time Frame: 6 weeks and 12 weeks ]
    uric acid in mg/dl
  • creatinine [ Time Frame: 6 weeks and 12 weeks ]
    creatinine in mg/dl
  • urea [ Time Frame: 6 weeks and 12 weeks ]
    urea in mg/dl
  • alanine amino transferase [ Time Frame: 6 weeks and 12 weeks ]
    alanine amino transferase in U/L
  • alkaline phosphatase [ Time Frame: 6 weeks and 12 weeks ]
    alkaline phosphatase in U/L
  • lactic dehydrogenase [ Time Frame: 6 weeks and 12 weeks ]
    lactic dehydrogenase in U/L
  • glycosylated hemoglobin [ Time Frame: 6 weeks and 12 weeks ]
    glycosylated hemoglobin in percentage
  • total bilirubin [ Time Frame: 6 weeks and 12 weeks ]
    total bilirubin in mg/dl
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
Official Title  ICMJE Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE PreDiabetes
Intervention  ICMJE
  • Drug: Curcumin
    Oral supplementation with curcumin 500 mg oral dosing for 3 months
  • Drug: Starch
    Oral supplementation with starch 500 mg oral dosing for 3 months
Study Arms  ICMJE
  • Experimental: Curcumin and bioperine
    This group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months
    Intervention: Drug: Curcumin
  • Placebo Comparator: Placebo
    This group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months
    Intervention: Drug: Starch
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Hu GX, Lin H, Lian QQ, Zhou SH, Guo J, Zhou HY, Chu Y, Ge RS. Curcumin as a potent and selective inhibitor of 11β-hydroxysteroid dehydrogenase 1: improving lipid profiles in high-fat-diet-treated rats. PLoS One. 2013;8(3):e49976. doi: 10.1371/journal.pone.0049976. Epub 2013 Mar 22.
  • Nagabhushan M, Bhide SV. Curcumin as an inhibitor of cancer. J Am Coll Nutr. 1992 Apr;11(2):192-8.
  • 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.
  • 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.
  • 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.4715. Epub 2012 May 21.
  • 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. 2014 Feb 11;2014:898361. doi: 10.1155/2014/898361. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2019) 		142
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917784
Other Study ID Numbers  ICMJE DI/18/111/03/067
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Identified individual participant data for all primary and secondary outcomes measures will be made avaliable
Supporting Materials: Study Protocol
Time Frame: Data will be avaliable whithin 6 months of study completion
Responsible Party César Leonardo González Aguilar, Hospital General de México Dr. Eduardo Liceaga
Study Sponsor  ICMJE Hospital General de México Dr. Eduardo Liceaga
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital General de México Dr. Eduardo Liceaga
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP