NCT03029390

Effect of Administration of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes

Status unknown Phase 4 Last updated 22 May 2023

What this trial tests

Phase 4 trial testing Berberine in Prediabetes in 28 participants. Status unknown.

Timeline

1 March 2016

Primary endpoint
1 February 2018

1 December 2023

Quick facts

Lead sponsor	University of Guadalajara
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	28
Start date	1 March 2016
Primary completion	1 February 2018
Estimated completion	1 December 2023
Sites	1 location across Mexico

Drugs / interventions tested

• Berberine — full drug profile →
• Metformin (metformin) — full drug profile →

Conditions studied

• Prediabetes — all drugs for Prediabetes →
• Impaired Fasting Glucose — all drugs for Impaired Fasting Glucose →
• Impaired Glucose Tolerance — all drugs for Impaired Glucose Tolerance →

Sponsor

University of Guadalajara

Who can join

Adults 31 to 60, any sex, with Prediabetes or Impaired Fasting Glucose. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Fasting glucose levels
  Time frame: Baseline to week 14
  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
• postprandial glucose levels
  Time frame: baseline to week 14
  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
• Glycosylated hemoglobin
  Time frame: baseline to week 14
  Glycosylated hemoglobin will be evaluated at baseline and week 14 by Elisa and the entered values reflect the glycosylated hemoglobin at week 14
• Total insulin secretion
  Time frame: baseline to week 14
  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
• First phase of insulin secretion
  Time frame: baseline to week 14
  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
• Insulin sensitivity
  Time frame: baseline to week 14
  Insulin sensitivity will be calculated at baseline and week 14 with Matsuda index and the entered values reflect the insulin sensitivity at week 14

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multi-target regulation of intestinal microbiota by berberine to improve type 2 diabetes mellitus.
   He Q, Dong H, Guo Y, Gong M, et al · · 2022 · cited 13× · PMID 36465656 · DOI 10.3389/fendo.2022.1074348