Clinical trial NCT02621060: Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Official title: Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Glucose Tolerance
Keywords: Chlorogenic acid
Control glucose
Insulin Secretion
Insulin Sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting Plasma Glucose (FPG)
timeFrame: Week 12.
measure: 2 Hours Plasma Glucose (2-h PG)
timeFrame: Week 12.
measure: Glycated Hemoglobin A1c (A1C)
timeFrame: Week 12.
measure: Total Insulin Secretion
timeFrame: Week 12.
measure: First Phase of Insulin Secretion
timeFrame: Week 12.
measure: Insulin Sensitivity
timeFrame: Week 12.
Secondary outcomes:
measure: Area Under the Curve of Glucose
timeFrame: Week 12.
measure: Area Under the Curve of Insulin
timeFrame: Week 12.
measure: Body Weight
timeFrame: Week 12.
measure: Body Mass Index
timeFrame: Week 12.
measure: Waist Circumference (WC)
timeFrame: Week 12.
measure: Systolic Blood Pressure (SBP)
timeFrame: Week 12.
measure: Diastolic Blood Plessure (DBP)
timeFrame: Week 12.
measure: Triglycerides (TG)
timeFrame: Week 12.
measure: Total Cholesterol (TC)
timeFrame: Week 12.
measure: High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Week 12.
measure: Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Week 12.
measure: Very-low Density Lipoprotein (VLDL)
timeFrame: Week 12.
measure: Glutamic Pyruvic Transaminase (GPT)
timeFrame: Week 12.
measure: Glutamic Oxaloacetic Transaminase (GOT)
timeFrame: Week 12.
measure: Creatinine
timeFrame: Week 12.
measure: Uric Acid
timeFrame: Week 12.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Esperanza Martínez, PhD Science
role: STUDY_DIRECTOR
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