Combination of Metformine/Inulin Versus Metformin on Prostate Benign Hyperplasia in Metabolic Syndrome

NCT02778776 | Completed Phase 3

• 1 other identifier: CUCS-INTEC-MV-HBP-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

Metformin; Agave Inulin; METS; Inflammation parameters; Urodynamic parameters; Prostate hyperplasia

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score (I-PSS)

  before and after intervention questionnaire

  12 weeks

Secondary Outcomes (11)

• Change of waist circumference

  12 weeks

• Change of body mass index

  12 weeks

• Change from baseline in Peripheral systolic blood pressure

  12 weeks

• Change from baseline in Peripheral diastolic blood pressure

  12 weeks

• Change of HOMA-IR from base line to 12 weeks

  12 weeks

Study Arms (4)

Agave inulin + Metfomin

EXPERIMENTAL

5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs

Drug: Metformin; Dietary Supplement: Agave inulin

Metformin + Placebo of agave inulin

ACTIVE COMPARATOR

500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder

Drug: Metformin; Other: Placebo of agave inulin

Agave Inulin+Placebo of Metformin

ACTIVE COMPARATOR

5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs

Dietary Supplement: Agave inulin; Other: Metformin placebo

Placebo of Inulin + Placebo of Metformin

PLACEBO COMPARATOR

5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs

Other: Placebo of agave inulin; Other: Metformin placebo

Interventions

Metformin DRUG

Metfomin in tablet presentation of 500 mg

Also known as: GLUCOPHAGE

Agave inulin + Metfomin; Metformin + Placebo of agave inulin

Agave inulin DIETARY_SUPPLEMENT

Oligofructan in powder obtained from agave plant, it was given to each patient a full 10 mg container.

Agave Inulin+Placebo of Metformin; Agave inulin + Metfomin

Placebo of agave inulin OTHER

Calcinated magnesia powder

Metformin + Placebo of agave inulin; Placebo of Inulin + Placebo of Metformin

Metformin placebo OTHER

Calcinated magnesia tablet

Agave Inulin+Placebo of Metformin; Placebo of Inulin + Placebo of Metformin

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metabolic syndrome by IDF criteria
• a person to be defined as having the metabolic syndrome they must have: Central obesity (defined as waist circumference\* with ethnicity specific values) ≥80 cm in females and ≥90 cm in males; and plus any two of the following four factors:
• Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL cholesterol
• \< 40 mg/dL (1.03 mmol/L) in males \< 50 mg/dL (1.29 mmol/L) in females or specific treatment for this lipid abnormality
• Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
• Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
• Age ranging from 40 to 80 years old
• Male patients
• Informed written consent

You may not qualify if:

• Kidney disease
• Hepatic disease
• Thyroid disease
• Diabetes mellitus
• Ischemic heart disease
• Drug consumption
• Alcohol consumption of more than 2 ounces daily
• Consumption of drugs that intervene with lipid or glucose metabolism 2 months before
• Blood pressure \>160/100mmHg.
• Lack of adherence to treatment (adherence \<80%)

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, México, 44100, Mexico

Location

MeSH Terms

Conditions

Metabolic Syndrome; Prostatic Hyperplasia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• FERNANDO GROVER, PhD

  Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fernando Grover-Paez, PhD

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 20, 2016
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)