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
Verified date | June 2019 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
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
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* Note: There are 11 references in all — Click here to view all references
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. |
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