Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Guadalajara
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Fasting Plasma Glucose (FPG)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI: 30.0-34.99 kg / m
- •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.
- •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.
Arms & Interventions
Placebo
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Intervention: Placebo (Drug)
Chlorogenic acid
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Intervention: Chlorogenic acid (Drug)
Outcomes
Primary Outcomes
Fasting Plasma Glucose (FPG)
Time Frame: Week 12.
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
2 Hours Plasma Glucose (2-h PG)
Time Frame: 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)
Time Frame: 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
Time Frame: Week 12.
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
First Phase of Insulin Secretion
Time Frame: Week 12.
After intervention with Stumvoll index
Insulin Sensitivity
Time Frame: Week 12.
After intervention Matsuda Index
Secondary Outcomes
- Area Under the Curve of Glucose(Week 12.)
- Area Under the Curve of Insulin(Week 12.)
- Body Weight(Week 12.)
- Body Mass Index(Week 12.)
- Waist Circumference (WC)(Week 12.)
- Systolic Blood Pressure (SBP)(Week 12.)
- Triglycerides (TG)(Week 12.)
- Total Cholesterol (TC)(Week 12.)
- High-density Lipoprotein Cholesterol (HDL-C)(Week 12.)
- Diastolic Blood Plessure (DBP)(Week 12.)
- Low-density Lipoprotein Cholesterol (LDL-C)(Week 12.)
- Very-low Density Lipoprotein (VLDL)(Week 12.)
- Glutamic Pyruvic Transaminase (GPT)(Week 12.)
- Glutamic Oxaloacetic Transaminase (GOT)(Week 12.)
- Creatinine(Week 12.)
- Uric Acid(Week 12.)
Investigators
Esperanza Martínez-Abundis
Researcher Professor
University of Guadalajara