Prediabetes Clinical Trial
Official title:
Effect of Administration of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes
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.
A randomized, double-blind, placebo-controlled clinical trial in 28 patients with a diagnosis of prediabetes (IFG and IGT) in accordance with the American Diabetes Association with out treatment. They will be assigned randomly two groups of 14 patients, one of the groups will receive 850 mg of metformin twice at day (before breakfast and before dinner) and one pill of placebo (before lunch) for 14 weeks. There will be a running period, starting with a dose of 500 mg the first week, the second week increasing to 1000 mg and from the third to the fourteenth week will be a dose of 1500 mg. The other group will receive 500 mg of berberine three times at day (each one before the mealtime) for14 weeks. There will be a running period, starting with a dose of 850 mg the first week, the second week dose of 850 mg of metformin plus one placebo pill and from the third week to the fourteenth week will be a dose of 1700 mg ( two 850 mg metformin pills) plus one placebo pill. They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated Area Under Curve of glucose and insulin, total insulin secretion (Insolinogenic index), first-phase of insulin secretion (Strumvoll index) and insulin sensitivity (Matsuda index). This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentage for qualitative variable. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p≤0.05. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Completed |
NCT03188263 -
Morning Light Treatment to Improve Glucose Metabolism
|
N/A | |
Recruiting |
NCT03821961 -
18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery
|
N/A | |
Completed |
NCT04303468 -
Intervention With a GABA Supplement in Prediabetics
|
N/A | |
Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
Completed |
NCT03675360 -
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
|
N/A | |
Completed |
NCT01910051 -
Explorative Assessment of Biomarkers in Overweight and Obese Subjects
|
||
Completed |
NCT03527368 -
The Time-Restricted Intake of Meals Study
|
N/A | |
Not yet recruiting |
NCT06453278 -
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
|
||
Suspended |
NCT03240978 -
Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese
|
N/A | |
Completed |
NCT03865342 -
Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT02899390 -
Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
|
N/A | |
Recruiting |
NCT01972113 -
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
|
N/A | |
Completed |
NCT01432509 -
Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)
|
N/A | |
Completed |
NCT01436916 -
Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT00990184 -
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
|
Phase 3 | |
Completed |
NCT00886340 -
A Lifestyle Change Program to Prevent Type 2 Diabetes
|
Phase 2 |