Glucose Tolerance Clinical Trial
Official title:
Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults
Verified date | February 2019 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Previous preclinical investigations have found that Medicago sativa promotes the decrease of glucose concentrations. To evaluate the acute effect of Medicago sativa administration on glucose tolerance, insulin secretion, and insulin sensitivity in healthy individuals.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 30, 2018 |
Est. primary completion date | January 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Fasting plasma glucose =99 mg/dL. - Two hours postload plasma glucose (100 a 139 mg/dL). - Body mass Index: 25 -39.9 kg/m2. - 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. - Sedentary. - Nonsmokers. - Body weight unchanged upper to 5% for at least 3 moths before the study. Exclusion Criteria: - Women in pregnancy and/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 prediabetes: Fasting plasma glucose =100 mg/dL and/or 2h-OGTT =140mg/dL and/or glycated hemoglobin A1c (A1C) between 5.7 - 6-4 %. - Diagnosis of Type 2 Diabetes Mellitus (T2DM): Fasting glucose = 126 mg / dL and/or 2h-OGTT = 200 mg/dL . - Total Cholesterol = 280 mg/dL. - Triglycerides = 300 mg/dL. - Known allergy to calcined magnesia or Medicago sativa. |
Country | Name | City | State |
---|---|---|---|
Mexico | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Abdul-Ghani M, DeFronzo RA, Jayyousi A. Prediabetes and risk of diabetes and associated complications: impaired fasting glucose versus impaired glucose tolerance: does it matter? Curr Opin Clin Nutr Metab Care. 2016 Sep;19(5):394-399. doi: 10.1097/MCO.0000000000000307. — View Citation
Gawel E. Chemical composition of lucerne leaf extract (EFL) and its applications as a phytobiotic in human nutrition. Acta Sci Pol Technol Aliment. 2012 Jul-Sep;11(3):303-10. Review. — View Citation
Stumvoll M, Mitrakou A, Pimenta W, Jenssen T, Yki-Järvinen H, Van Haeften T, Renn W, Gerich J. Use of the oral glucose tolerance test to assess insulin release and insulin sensitivity. Diabetes Care. 2000 Mar;23(3):295-301. — View Citation
Tai MM. A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care. 1994 Feb;17(2):152-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fasting plasma glucose (FPG) | Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L. | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | |
Primary | 2 hour oral glucose tolerance test (2h-PG) | Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | |
Primary | First Phase of Insulin Secretion | calculated as 1283 + 1.829 x insulin 30' (mmol/L) - 138.7 x glucose 30' + 3.772 x insulin 0' (pmol/L). | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | |
Primary | Total Insulin Secretion | Insulinogenic index calculated as ?AUC insulin /(?AUC glucose | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | |
Primary | Insulin sensitivity | Matsuda index (insulin sensitivity) calculated as [10,000/square root of (glucose 0' X insulin 0')] (mean glucose X mean insulin during 2h-OGTT)] | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | |
Secondary | Body Weight | Measured with minimal clothing and bare feet | At baseline of the study | |
Secondary | Body Mass Index (BMI) | Calculated with the Quetelet index | At baseline of the study | |
Secondary | Waist circumference (WC) | Measured with a flexible tape in them id point between the lowest rib and the iliac crest and is expressed in centimeters. | At baseline of the study | |
Secondary | Systolic blood pressure (SBP) | Evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure expressed on mmHg | At baseline of the study | |
Secondary | Diastolic Blood pressure (DBP) | Evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of diastolic blood pressure expressed on mmHg | At baseline of the study | |
Secondary | Total Cholesterol (TC) | Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L. | At baseline of the study | |
Secondary | Triglycerides (TG) | Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L. | At baseline of the study | |
Secondary | High Density Lipoprotein Cholesterol (HDL- C) | Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L. | At baseline of the study | |
Secondary | Low Density Lipoprotein Cholesterol (LDL-C) | Determined after overnight fasting (10 to 12-h), calculated with the Friedewald equation LDL-C (mmol/L) = TC (mmol/L) - HDL-C (mmol/L) - [TG (mmol/L)/2.2] and very low-density lipoprotein (VLDL) for the proportion of TG (mmol/L)/2.2. Expressed in mmol/L. | At baseline of the study | |
Secondary | Very Low Density Lipoprotein (VLDL) | Estimated by standardized techniques | At baseline of the study | |
Secondary | Levels of aspartate aminotransferase in blood | Estimated by standardized techniques | At baseline of the study | |
Secondary | Levels of alanine aminotransferase in blood | Estimated by standardized techniques | At baseline of the study | |
Secondary | Levels of creatinine in blood | Estimated by standardized techniques | At baseline of the study | |
Secondary | Levels of uric acid in blood | Estimated by standardized techniques | At baseline of the study |
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