Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

University of Guadalajara30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Impaired Glucose Tolerance

Interventions

PlaceboDRUG

Placebo: 1200 mg per day for three months

Chlorogenic acidDRUG

Chologenic acid: 1200 mg per day for three months

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Fasting Plasma Glucose (FPG)

Reflect the fasting glucose level after a 10- to 12-h overnight fast.

Time frame: 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.

Time frame: 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.

Time frame: Week 12.

Total Insulin Secretion

After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).

Time frame: Week 12.

First Phase of Insulin Secretion

After intervention with Stumvoll index

Time frame: Week 12.

Insulin Sensitivity

After intervention Matsuda Index

Time frame: Week 12.

Secondary Outcomes

Area Under the Curve of Glucose

Area under the curve of glucose was obtained using the trapezoidal integration.

Time frame: Week 12.

Area Under the Curve of Insulin

Before and after intervention area under the curve of insulin

Time frame: Week 12.

Data from ClinicalTrials.gov

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