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Completed

NCT Number: NCT01754792

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Healthy Hyperglycemia Impaired Glucose Tolerance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dr Peset

Valencia, 46017, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pinitol

Dietary Supplement

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 names: 3-O-methyl-D-chiro-inositol

Primary outcomes

  1. To assess hidrocarbonated metabolism parameters before and after pinitol/placebo administration

    Time frame: 3 months

    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 outcomes

  1. To evaluate lipid parameters before and after pinitol/placebo administration

    Time frame: 3 months

    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.

  2. To evaluate inflammatory parameters before and after pinitol/placebo administration

    Time frame: 3 months

    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.

  3. To evaluate endothelial function before and after pinitol/placebo administration

    Time frame: 3 months

    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

  4. To evaluate oxidative stress on mitochondrial function before and after pinitol/placebo administration

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2012
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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