Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

Phase 2

Completed

Conditions: Impaired Glucose Tolerance

Interventions: Drug: Placebo
Drug: Chlorogenic acid

Registration Number: NCT02621060

Lead Sponsor: University of Guadalajara

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid	Chlorogenic acid	1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG)	Week 12.	Reflect the fasting glucose level after a 10- to 12-h overnight fast.
2 Hours Plasma Glucose (2-h PG)	Week 12.	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.
Glycated Hemoglobin A1c (A1C)	Week 12.	Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.
Total Insulin Secretion	Week 12.	After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
First Phase of Insulin Secretion	Week 12.	After intervention with Stumvoll index
Insulin Sensitivity	Week 12.	After intervention Matsuda Index

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve of Glucose	Week 12.	Area under the curve of glucose was obtained using the trapezoidal integration.
Area Under the Curve of Insulin	Week 12.	Before and after intervention area under the curve of insulin
Body Weight	Week 12.	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
Body Mass Index	Week 12.	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
Waist Circumference (WC)	Week 12.	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
Systolic Blood Pressure (SBP)	Week 12.	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
Triglycerides (TG)	Week 12.	The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12
Total Cholesterol (TC)	Week 12.	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
High-density Lipoprotein Cholesterol (HDL-C)	Week 12.	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
Diastolic Blood Plessure (DBP)	Week 12.	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
Low-density Lipoprotein Cholesterol (LDL-C)	Week 12.	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
Very-low Density Lipoprotein (VLDL)	Week 12.	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
Glutamic Pyruvic Transaminase (GPT)	Week 12.	Before and after intervention by spectrophotometry
Glutamic Oxaloacetic Transaminase (GOT)	Week 12.	Before and after intervention by spectrophotometry
Creatinine	Week 12.	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
Uric Acid	Week 12.	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.