NCT02778776

Effect of Administration of Combination Metformine/Inulin Versus Metformine on Patients With Prostate Benign Hyperplasia and Metabolic Syndrome Syndrome

Completed Phase 3 Last updated 19 May 2016

What this trial tests

Phase 3 trial testing Metformin in Metabolic Syndrome in 40 participants. Completed in 1 June 2015.

Timeline

1 January 2013

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Centro Universitario de Ciencias de la Salud, Mexico
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 January 2013
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	1 location across Mexico

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Agave inulin — full drug profile →
• Placebo of agave inulin
• Metformin placebo

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico — full company profile →

Who can join

Adults 40 to 80, male only, with Metabolic Syndrome. 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.

• International Prostate Symptom Score (I-PSS)
  Time frame: 12 weeks
  before and after intervention questionnaire

Sponsor's own description

Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid metabolism, especially triglyceride and hypertension are metabolic disorders that play a central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular morbidity and mortality associated with atherosclerosis, such as myocardial infarction, cerebral vascular events, vascular dementia, heart failure and end stage renal disease. Recently other complications related with hyperinsulinemia like the prostate benign hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome, given its low cost and comparable pharmacological effects to the tiazolinedionas (eg pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty acids and triglycerides, also it produces moderate weight loss, improving the metabolic profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes mellitus in individuals with impaired fasting glucose.

A second option for risk reduction would be the addition of inulin fiber type as it has been demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.

It is expected that combination of metformin with inulin produce a beneficial effect through farmacological synergism and the impact on fisiopatological changes of metabolic syndrome that potentially is considered as an important risk factor for prostate growth.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Mitochondrial OXPHOS and Their Regulatory Signals in Prostate Cancers.
   Chen CL, Lin CY, Kung HJ. · · 2021 · cited 39× · PMID 34948229 · DOI 10.3390/ijms222413435
2. RepurposeDrugs: an interactive web-portal and predictive platform for repurposing mono- and combination therapies.
   Ianevski A, Kushnir A, Nader K, Miihkinen M, et al · · 2024 · cited 15× · PMID 38980370 · DOI 10.1093/bib/bbae328