Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

Impaired Glucose Tolerance Clinical Trial

Official title:

Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621060
• Other study ID #: CT-ACG-271281-LYZ
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2019
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control, obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show that Chlorogenic acid has an excellent potential for the control of glucose as well as insulin secretion and insulin sensitivity.

Description:

A randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients with a diagnosis of impaired glucose tolerance in accordance with the American Diabetes Association criteria. The patients received 400 mg capsules of Chlorogenic acid or placebo, three times daily 1/ 2 hour before meals for 90 days. Before and after intervention the investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (A1C), triglycerides, high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI: 30.0-34.99 kg / m2.

• Diagnosis of IGT (OGTT Values between 140mg / dl and 199mg / dl.

• Written informed consent.

• Body weight stable over the last 3 months.

• Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.

• Women who are not contemplated get pregnant within the next 6 months.

Exclusion Criteria:

• Women pregnant or breastfeeding.

• Physical or mental disability that makes it impossible to perform the intervention.

• Diagnosis of Hypertension or heart failure.

• Smokers.

• Untreated thyroid disease.

• Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).

• Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.

• Diagnosis of renal disease or creatinine > 1.5 mg / dl.

• Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose = 126 mg / dL and/or OGTT = 200 mg / dL and/or A1C = 6.5%.

• Total Cholesterol = 280 mg/dL.

• Triglycerids = 300 mg/dL.

• Known allergy to calcined magnesia or Chorogenic acid.

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• Insulin Resistance

Intervention

Drug:
• Placebo
Placebo: 1200 mg per day for three months
• Chlorogenic acid
Chologenic acid: 1200 mg per day for three months

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

Adeney KL, Williams MA, Schiff MA, Qiu C, Sorensen TK. Coffee consumption and the risk of gestational diabetes mellitus. Acta Obstet Gynecol Scand. 2007;86(2):161-6. — View Citation

American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015 Apr;33(2):97-111. doi: 10.2337/diaclin.33.2.97. — View Citation

Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, Davidson MB, Einhorn D, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez G, Davidson MH; American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013 Mar-Apr;19(2):327-36. — View Citation

Garber AJ, Handelsman Y, Einhorn D, Bergman DA, Bloomgarden ZT, Fonseca V, Garvey WT, Gavin JR 3rd, Grunberger G, Horton ES, Jellinger PS, Jones KL, Lebovitz H, Levy P, McGuire DK, Moghissi ES, Nesto RW. Diagnosis and management of prediabetes in the continuum of hyperglycemia: when do the risks of diabetes begin? A consensus statement from the American College of Endocrinology and the American Association of Clinical Endocrinologists. Endocr Pract. 2008 Oct;14(7):933-46. — View Citation

Guerrero-Romero F, Rodríguez-Morán M, Pérez-Fuentes R, Sánchez-Guillén MC, González-Ortiz M, Martínez-Abundis E, Brito-Zurita O, Madero A, Figueroa B, Revilla-Monsalve C, Flores-Martínez SE, Islas-Andrade S, Rascón-Pacheco RA, Cruz M, Sánchez-Corona J. Prediabetes and its relationship with obesity in Mexican adults: The Mexican Diabetes Prevention (MexDiab) Study. Metab Syndr Relat Disord. 2008 Mar;6(1):15-23. doi: 10.1089/met.2007.0020. — View Citation

McCarty MF. A chlorogenic acid-induced increase in GLP-1 production may mediate the impact of heavy coffee consumption on diabetes risk. Med Hypotheses. 2005;64(4):848-53. — View Citation

Olthof MR, Hollman PC, Katan MB. Chlorogenic acid and caffeic acid are absorbed in humans. J Nutr. 2001 Jan;131(1):66-71. — View Citation

Renouf M, Marmet C, Giuffrida F, Lepage M, Barron D, Beaumont M, Williamson G, Dionisi F. Dose-response plasma appearance of coffee chlorogenic and phenolic acids in adults. Mol Nutr Food Res. 2014 Feb;58(2):301-9. doi: 10.1002/mnfr.201300349. Epub 2013 Sep 4. — View Citation

Shaw JE, Zimmet PZ, de Courten M, Dowse GK, Chitson P, Gareeboo H, Hemraj F, Fareed D, Tuomilehto J, Alberti KG. Impaired fasting glucose or impaired glucose tolerance. What best predicts future diabetes in Mauritius? Diabetes Care. 1999 Mar;22(3):399-402. — View Citation

van Popele NM, Elizabeth Hak A, Mattace-Raso FU, Bots ML, van der Kuip DA, Reneman RS, Hoeks AP, Hofman A, Grobbee DE, Witteman JC. Impaired fasting glucose is associated with increased arterial stiffness in elderly people without diabetes mellitus: the Rotterdam Study. J Am Geriatr Soc. 2006 Mar;54(3):397-404. — View Citation

Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose (FPG)	Reflect the fasting glucose level after a 10- to 12-h overnight fast.	Week 12.
Primary	2 Hours Plasma Glucose (2-h PG)	Subjects underwent a 2-h oral glucose tolerance test (2-h OGTT) by consuming 75-g of a dextrose load, and one sample was obtained 120 min after glucose administration.	Week 12.
Primary	Glycated Hemoglobin A1c (A1C)	Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.	Week 12.
Primary	Total Insulin Secretion	After intervention. Total insulin secretion was calculated with the Insulinogenic index (? ABC insulin / ? ABC glucose).	Week 12.
Primary	First Phase of Insulin Secretion	After intervention with Stumvoll index	Week 12.
Primary	Insulin Sensitivity	After intervention Matsuda Index	Week 12.
Secondary	Area Under the Curve of Glucose	Area under the curve of glucose was obtained using the trapezoidal integration.	Week 12.
Secondary	Area Under the Curve of Insulin	Before and after intervention area under the curve of insulin	Week 12.
Secondary	Body Weight	The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12	Week 12.
Secondary	Body Mass Index	The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12	Week 12.
Secondary	Waist Circumference (WC)	Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12	Week 12.
Secondary	Systolic Blood Pressure (SBP)	The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12	Week 12.
Secondary	Diastolic Blood Plessure (DBP)	The Diastolic blood plessure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12	Week 12.
Secondary	Triglycerides (TG)	The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12	Week 12.
Secondary	Total Cholesterol (TC)	The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12	Week 12.
Secondary	High-density Lipoprotein Cholesterol (HDL-C)	The HDL-C levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the HDL-C level at week 12	Week 12.
Secondary	Low-density Lipoprotein Cholesterol (LDL-C)	The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the LDL-C levels at week 12	Week 12.
Secondary	Very-low Density Lipoprotein (VLDL)	The VLDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12	Week 12.
Secondary	Glutamic Pyruvic Transaminase (GPT)	Before and after intervention by spectrophotometry	Week 12.
Secondary	Glutamic Oxaloacetic Transaminase (GOT)	Before and after intervention by spectrophotometry	Week 12.
Secondary	Creatinine	The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12	Week 12.
Secondary	Uric Acid	The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinina levels at week 12.	Week 12.