Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Drug: Placebo
* Drug: Chlorogenic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. | Drug: Placebo<br>* Placebo: 1200 mg per day for three months<br>* Other names: Calcined magnesia;|
| Experimental: Chlorogenic acid<br>1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. | Drug: Chlorogenic acid<br>* Chologenic acid: 1200 mg per day for three months<br>* Other names: 3-O-Caffeoylquinic, acid Heriguard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) | Reflect the fasting glucose level after a 10- to 12-h overnight fast. | Week 12. | 
| 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. | 
| 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. | 
| Total Insulin Secretion | After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose). | Week 12. | 
| First Phase of Insulin Secretion | After intervention with Stumvoll index | Week 12. | 
| Insulin Sensitivity | After intervention Matsuda Index | Week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve of Glucose | Area under the curve of glucose was obtained using the trapezoidal integration. | Week 12. | 
| Area Under the Curve of Insulin | Before and after intervention area under the curve of insulin | Week 12. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| Glutamic Pyruvic Transaminase (GPT) | Before and after intervention by spectrophotometry | Week 12. | 
| Glutamic Oxaloacetic Transaminase (GOT) | Before and after intervention by spectrophotometry | Week 12. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorogenic acid, Control glucose, Insulin Secretion, Insulin Sensitivity