Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Valencia
Sponsor:
Information provided by (Responsible Party):
Antonio Hernández Mijares, University of Valencia
ClinicalTrials.gov Identifier:
NCT01754792
First received: December 13, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic, impaired and normal fasting glucose subjects.

This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design. Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.


Condition Intervention
Type 2 Diabetes
Impaired Glucose Tolerance
Healthy
Dietary Supplement: Pinitol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Study on the Influence of Pinitol on Carbohydrate, Lipid and Inflammatory Parameters, Endothelial Function and Oxidative Stress in Diabetic, Impaired and Normal Fasting Glucose Subjects

Resource links provided by NLM:


Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • To assess hidrocarbonated metabolism parameters before and after pinitol/placebo administration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    Blood samples were collected in vacutainer serum separator tubes, after 12- hour overnight fasting, to analyze glucose and insulin concentration at baseline (after a four weeks run-in period of a healthy diet), 6 and 12 weeks after pinitol/placebo administration. Glucose concentrations were measured by means of enzymatic assay in an autoanalyzer. Insulin concentrations were determined by enzyme-linked immunosorbent assay.

    In a representative group of patients of all groups at time 0 and 10 weeks, a 24 hours glucose levels control were assessed (by means of a continuous glucose monitoring system) for 3 days.

    Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR) index (fasting insulin (μIU/ml) x fasting glucose (mg/dl) /405). Glycosylated hemoglobin (HbA1c) was measured at baseline and 12 weeks in diabetic and impaired fasting glucose subjects.



Secondary Outcome Measures:
  • To evaluate lipid parameters before and after pinitol/placebo administration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Total cholesterol and triglycerides were measured by means of enzymatic assays and HDL cholesterol concentrations were recorded using a direct method with an autoanalyzer. LDL cholesterol concentration was calculated using the Friedewald method. Non-HDL cholesterol concentration was obtained by calculating the difference between total and HDL cholesterol. Atherogenic index of plasma was obtained by calculating the logarithm of the ratio of plasma concentration of triglycerides to HDL-cholesterol. Apolipoprotein A-I and B were determined by immunonephelometry. These parameters were measured at baseline, 6 and 12 weeks after pinitol/placebo administration.

  • To evaluate inflammatory parameters before and after pinitol/placebo administration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The evaluation of the inflammatory state was assessed by determination of the concentrations of high sensitive C-reactive protein (hsCRP)(by a latexenhanced immunonephelometric assay) and interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α) by xMAP Multiplex technology on the Luminex. These parameters were measured at baseline, 6 and 12 weeks after pinitol/placebo administration.

  • To evaluate endothelial function before and after pinitol/placebo administration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    E-selectin, ICAM-1 and VCAM-1 were measured by xMAP Multiplex technology on the Luminex at baseline, 6 and 12 weeks after pinitol/placebo administration

  • To evaluate oxidative stress on mitochondrial function before and after pinitol/placebo administration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Mitochondrial production of reactive oxygen species, levels of calcium, mitochondrial membrane potential and mitochondrial activity were measured at baseline, 6 and 12 weeks after pinitol/placebo administration


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal fasting glucose subjects
Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.
Dietary Supplement: Pinitol
Fruit Up® (diluted with mineral water to a final volume of 250 ml) will be evaluated, and will be equivalent to an intake of 2 g of pinitol. The placebo beverage will contain equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
Other Name: 3-O-methyl-D-chiro-inositol
Experimental: Impaired fasting glucose subjects
Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.
Dietary Supplement: Pinitol
Fruit Up® (diluted with mineral water to a final volume of 250 ml) will be evaluated, and will be equivalent to an intake of 2 g of pinitol. The placebo beverage will contain equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
Other Name: 3-O-methyl-D-chiro-inositol
Experimental: Diabetic subjects
Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.
Dietary Supplement: Pinitol
Fruit Up® (diluted with mineral water to a final volume of 250 ml) will be evaluated, and will be equivalent to an intake of 2 g of pinitol. The placebo beverage will contain equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
Other Name: 3-O-methyl-D-chiro-inositol

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age range of 18-70 years.
  • Normal fasting glucose subjects were diagnosed as fasting glucose <100 mg/dl and HbA1c <5.7%.
  • Impaired fasting glucose subjects were diagnosed as fasting glucose between 100 and 125 mg/dl and/or HbA1c between 5.7 and 6.4%.
  • Type 2 Diabetes subjects were diagnosed as basal plasma glucose ≥ 126 mg/dl, at least twice, or glucose levels 2 hours after 75 g oral glucose overload ≥ 200 mg/dl (American Diabetes Association)

Exclusion criteria:

  • Morbid obesity
  • Type 1 diabetes
  • Heart, liver, thyroid or kidney untreated disease
  • Neoplasic disease
  • Hypertriglyceridemia (Triglycerides >400 mg/dl),
  • Use of drugs that can influence the inflammatory state or insulin sensitivity (NSAIDs, corticosteroids, antiTNFα) and
  • Uncontrolled type 2 diabetes (HbA1c ≥ 8%) or with insulin or intestinal disaccharidase inhibitors (acarbose, miglyol,...) treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754792

Locations
Spain
University Hospital Dr Peset Recruiting
Valencia, Spain, 46017
Contact: Antonio Hernández, Phd, MD    34 961622492    hernandez_antmij@gva.es   
Principal Investigator: Antonio Hernandez, Phd, MD         
Sponsors and Collaborators
University of Valencia
Investigators
Principal Investigator: Antonio Hernandez, MD, Phd Universtiy of Valencia
  More Information

No publications provided

Responsible Party: Antonio Hernández Mijares, PhD, MD, University of Valencia
ClinicalTrials.gov Identifier: NCT01754792     History of Changes
Other Study ID Numbers: WIL-PIN-2012-02
Study First Received: December 13, 2012
Last Updated: December 18, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on September 18, 2014