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

NCT01754792 | Completed

• 1 other identifier: WIL-PIN-2012-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Impaired Glucose Tolerance; Healthy

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months

Secondary Outcomes (4)

• To evaluate lipid parameters before and after pinitol/placebo administration

  3 months

• To evaluate inflammatory parameters before and after pinitol/placebo administration

  3 months

• To evaluate endothelial function before and after pinitol/placebo administration

  3 months

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

  3 months

Study Arms (3)

Normal fasting glucose subjects

EXPERIMENTAL

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

Impaired fasting glucose subjects

EXPERIMENTAL

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

Diabetic subjects

EXPERIMENTAL

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

Interventions

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.

Also known as: 3-O-methyl-D-chiro-inositol

Diabetic subjects; Impaired fasting glucose subjects; Normal fasting glucose subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University Hospital Dr Peset

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance

Interventions

pinitol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Antonio Hernandez, MD, Phd

  Universtiy of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 21, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

ES (1)