Prediabetes Clinical Trial
Official title:
Effect of Administration of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes
Verified date | June 2022 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher risk to develop type 2 diabetes mellitus (T2DM) in 10 years. The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, the traditional Chinese and Ayurverica medicine offer potential active substances for the treatment of hyperglucemia like berberine. Berberine is an extract with hypoglycemic effects in animal models as well as in clinical trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's activity against metformin in prediabetes would provide impact information on a new alternative treatment and compare with the standard pharmacological treatment. The aim of the study evaluate the effect of administration of berberine versus metaformine on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes. The investigators hypothesis is that the administration of berberine versus metformin modifies glycemic control, insulin sensitivity and insulin secretion in patients with prediabetes.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | December 2023 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 31 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients both sexes - Age between 31 and 60 years - Diagnosis of prediabetes according 2 ADA criteria (fasting blood glucose levels between 100-125 mg/dl and postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl) - Body Mass Index from 25 to 34.9kg/m2 - Informed consent signed Exclusion Criteria: - Women with confirmed or suspected pregnancy - Women under lactation and/or puerperium - Hypersensibility to ingredients of intervention - Physical impossibility for taking pills - Known uncontrolled renal, hepatic, heart or thyroid diseased - Diabetes diagnosis - Previous treatment for glucose - Body Mass Index =35 kg/m2 - Glycosylated hemoglobin > 6.5% - Triglycerides =500 mg/dL - Total cholesterol =240 mg/dL - Low density lipoprotein (c-LDL) =190 mg/dL - Blood Pressure =140/90 mmHg |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fasting glucose levels | The fasting glucose levels will be evaluated at baseline and week 14 with enzymatic/ colorimetric techniques and the entered values reflect the fasting glucose level at week 14 | Baseline to week 14 | |
Primary | postprandial glucose levels | Postprandial glucose will be evaluated at baseline week 14 after a oral glucose tolerance test with enzymatic/ colorimetric techniques and the entered values reflect the insulin sensitivity at week 14 | baseline to week 14 | |
Primary | Glycosylated hemoglobin | Glycosylated hemoglobin will be evaluated at baseline and week 14 by Elisa and the entered values reflect the glycosylated hemoglobin at week 14 | baseline to week 14 | |
Primary | Total insulin secretion | Total insulin secretion will be calculated at baseline and week 14 with insulinogenic index and the entered values reflect the total insulin secretion at week 14 | baseline to week 14 | |
Primary | First phase of insulin secretion | The first phase of insulin secretion will be calculated at baseline and week 14 with Strumvoll index and the entered values reflect the first phase of insulin secretion at week 14 | baseline to week 14 | |
Primary | Insulin sensitivity | Insulin sensitivity will be calculated at baseline and week 14 with Matsuda index and the entered values reflect the insulin sensitivity at week 14 | baseline to week 14 | |
Secondary | Body Weight | The body weight will be measured at baseline, week 3, week 6, week 10, and week 14 with a bioimpedance balance and the entered values reflect the body weight at week 14 | Baseline to week 14 | |
Secondary | Body Mass Index | Body Mas Index will be calculated at baseline, week 3, week 6, week 10, and week 14 with the Quetelet index formula and the entered values reflect the body mass index at week 14 | Baseline to week 14 | |
Secondary | Body fat percentage | Body fat percentage will be evaluated at baseline, week 3, week 6, week 10, and week 14 by Bioimpedance technique and the entered values reflect the body fat percentage at week 14 | Baseline to week 14 | |
Secondary | Waist circumference | Waist circumference will be evaluated at baseline, week 3, week 6, week 10 and week 14 by World Health Organization technique and the entered values reflect the waist circumference mesure at week 14 | Baseline to week 14 | |
Secondary | Blood pressure | Blood pressure will be measured at baseline,week 3, week 6, week 10 and week week 14 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 14 | Baseline to week 14 | |
Secondary | Total cholesterol | Total cholesterol levels will be evaluated at baseline and week 14 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 14 | Baseline to week 14 | |
Secondary | Triglycerides levels | Triglycerides levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 14 | Baseline to week 14 | |
Secondary | High density lipoprotein (c-HDL) levels | c-HDL levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 14 | Baseline to week 14 | |
Secondary | Low density lipoprotein (c-LDL) levels | c-LDL levels will be will be calculated at baseline and week 14 with Friedewald Formula and the entered values reflect the c-HDL level at week 14 | Baseline to week 14 | |
Secondary | Alanine aminotransferase (ALT) levels | ALT levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques | Baseline to week 14 | |
Secondary | Aspartate aminotransferase (AST) levels | AST levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques | Baseline to week 14 | |
Secondary | Creatinine levels | Creatinine levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques | Baseline to week 14 |
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