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Completed

NCT Number: NCT02621060

Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

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.

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Key information

Conditions

Impaired Glucose Tolerance Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo: 1200 mg per day for three months

Other names: Calcined magnesia

Chlorogenic acid

Drug

Chologenic acid: 1200 mg per day for three months

Other names: 3-O-Caffeoylquinic, acid Heriguard

Primary outcomes

  1. Fasting Plasma Glucose (FPG)

    Time frame: Week 12.

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

  2. 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.

  3. 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.

  4. Total Insulin Secretion

    Time frame: Week 12.

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

  5. First Phase of Insulin Secretion

    Time frame: Week 12.

    After intervention with Stumvoll index

  6. Insulin Sensitivity

    Time frame: Week 12.

    After intervention Matsuda Index

Secondary outcomes

  1. Area Under the Curve of Glucose

    Time frame: Week 12.

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

  2. Area Under the Curve of Insulin

    Time frame: Week 12.

    Before and after intervention area under the curve of insulin

  3. Body Weight

    Time frame: 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

  4. Body Mass Index

    Time frame: 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

  5. Waist Circumference (WC)

    Time frame: 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

  6. Systolic Blood Pressure (SBP)

    Time frame: 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

  7. Diastolic Blood Plessure (DBP)

    Time frame: 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

  8. Triglycerides (TG)

    Time frame: 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

  9. Total Cholesterol (TC)

    Time frame: 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

  10. High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: 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

  11. Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: 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

  12. Very-low Density Lipoprotein (VLDL)

    Time frame: 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

  13. Glutamic Pyruvic Transaminase (GPT)

    Time frame: Week 12.

    Before and after intervention by spectrophotometry

  14. Glutamic Oxaloacetic Transaminase (GOT)

    Time frame: Week 12.

    Before and after intervention by spectrophotometry

  15. Creatinine

    Time frame: 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

  16. Uric Acid

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2015
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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